Publications by authors named "Harry Staines"

39 Publications

Complement component 7 is associated with total- and cardiac death in chest-pain patients with suspected acute coronary syndrome.

BMC Cardiovasc Disord 2021 10 14;21(1):496. Epub 2021 Oct 14.

Department of Clinical Science, University of Bergen, Bergen, Norway.

Background: Complement activation has been associated with atherosclerosis, atherosclerotic plaque destabilization and increased risk of cardiovascular events. Complement component 7 (CC7) binds to the C5bC6 complex which is part of the terminal complement complex (TCC/C5b-9). High-sensitivity C-reactive protein (hsCRP) is a sensitive marker of systemic inflammation and may reflect the increased inflammatory state associated with cardiovascular disease.

Aim: To evaluate the associations between CC7 and total- and cardiac mortality in patients hospitalized with chest-pain of suspected coronary origin, and whether combining CC7 with hsCRP adds prognostic information.

Methods: Baseline levels of CC7 were related to 60-months survival in a prospective, observational study of 982 patients hospitalized with a suspected acute coronary syndrome (ACS) at 9 hospitals in Salta, Argentina. A cox regression model, adjusting for conventional cardiovascular risk factors, was fitted with all-cause mortality, cardiac death and sudden cardiac death (SCD) as the dependent variables. A similar Norwegian population of 871 patients was applied to test the reproducibility of results in relation to total death.

Results: At follow-up, 173 patients (17.7%) in the Argentinean cohort had died, of these 92 (9.4%) were classified as cardiac death and 59 (6.0%) as SCD. In the Norwegian population, a total of 254 patients (30%) died. In multivariable analysis, CC7 was significantly associated with 60-months all-cause mortality [hazard ratio (HR) 1.26 (95% confidence interval (CI), 1.07-1.47) and cardiac death [HR 1.28 (95% CI 1.02-1.60)], but not with SCD. CC7 was only weakly correlated with hsCRP (r = 0.10, p = 0.002), and there was no statistically significant interaction between the two biomarkers in relation to outcome. The significant association of CC7 with total death was reproduced in the Norwegian population.

Conclusions: CC7 was significantly associated with all-cause mortality and cardiac death at 60-months follow-up in chest-pain patients with suspected ACS.

Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT01377402, NCT00521976.
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http://dx.doi.org/10.1186/s12872-021-02306-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8515738PMC
October 2021

Colonoscopy quality across Europe: a report of the European Colonoscopy Quality Investigation (ECQI) Group.

Endosc Int Open 2021 Oct 16;9(10):E1456-E1462. Epub 2021 Sep 16.

Gastroenterology Unit, Department of Medical and Surgical Sciences, S. Orsola-Malpighi Hospital, Bologna, Italy.

The European Colonoscopy Quality Investigation (ECQI) Group comprises expert colonoscopists and investigators with the aim of raising colonoscopy standards. We assessed the levels of monitoring and achievement of European Society of Gastrointestinal Endoscopy (ESGE) performance measures (PMs) across Europe using responses to the ECQI questionnaires. The questionnaire comprises three forms: institution and practitioner questionnaires are completed once; a procedure questionnaire is completed on multiple occasions for individual total colonoscopies. ESGE PMs were approximated as closely as possible from the data collected via the procedure questionnaire. Procedure data could provide rate of adequate bowel preparation, cecal intubation rate (CIR), withdrawal time, polyp detection rate (PDR), and tattooing resection sites. We evaluated ECQI questionnaire data collected between June 2016 and April 2018, comprising 91 practitioner and 52 institution questionnaires. A total of 6445 completed procedure forms were received. Institution and practitioner responses indicate that routine recording of PMs is not widespread: adenoma detection rate (ADR) is routinely recorded in 29 % of institutions and by 34 % of practitioners; PDR by 42 % and 47 %, CIR by 62 % and 64 %, bowel preparation quality by 56 % and 76 %, respectively. Procedure data showed a rate of adequate bowel preparation of 84.2 %, CIR 73.4 %, PDR 40.5 %, mean withdrawal time 7.8 minutes and 12.2 % of procedures with possible removal of a non-pedunculated lesion ≥ 20 mm reporting tattooing. Our findings clearly show areas in need of quality improvement and the importance of promoting quality monitoring throughout the colonoscopy procedure.
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http://dx.doi.org/10.1055/a-1486-6729DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8445680PMC
October 2021

Angiopoietin-2 and angiopoietin-like 4 protein provide prognostic information in patients with suspected acute coronary syndrome.

J Intern Med 2021 10 8;290(4):894-909. Epub 2021 Jul 8.

Department of Cardiology, Stavanger University Hospital, Stavanger, Norway.

Background: Plasma levels of angiopoietin-2 (ANGPT2) and angiopoietin-like 4 protein (ANGPTL4) reflect different pathophysiological aspects of cardiovascular disease. We evaluated their association with outcome in a hospitalized Norwegian patient cohort (n = 871) with suspected acute coronary syndrome (ACS) and validated our results in a similar Argentinean cohort (n = 982).

Methods: A cox regression model, adjusting for traditional cardiovascular risk factors, was fitted for ANGPT2 and ANGPTL4, respectively, with all-cause mortality and cardiac death within 24 months and all-cause mortality within 60 months as the dependent variables.

Results: At 24 months follow-up, 138 (15.8%) of the Norwegian and 119 (12.1%) of the Argentinian cohort had died, of which 86 and 66 deaths, respectively, were classified as cardiac. At 60 months, a total of 259 (29.7%) and 173 (17.6%) patients, respectively, had died. ANGPT2 was independently associated with all-cause mortality in both cohorts at 24 months [hazard ratio (HR) 1.27 (95% confidence interval (CI), 1.08-1.50) for Norway, and HR 1.57 (95% CI, 1.27-1.95) for Argentina], with similar results at 60 months [HR 1.19 (95% CI, 1.05-1.35) (Norway), and HR 1.56 (95% CI, 1.30-1.88) (Argentina)], and was also significantly associated with cardiac death [HR 1.51 (95% CI, 1.14-2.00)], in the Argentinean population. ANGPTL4 was significantly associated with all-cause mortality in the Argentinean cohort at 24 months [HR 1.39 (95% CI, 1.15-1.68)] and at 60 months [HR 1.43 (95% CI, 1.23-1.67)], enforcing trends in the Norwegian population.

Conclusions: ANGPT2 and ANGPTL4 were significantly associated with outcome in similar ACS patient cohorts recruited on two continents.

Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT00521976. ClinicalTrials.gov Identifier: NCT01377402.
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http://dx.doi.org/10.1111/joim.13339DOI Listing
October 2021

Continuous Subcutaneous Apomorphine Infusion in Parkinson's Disease: A Single-Center, Long-Term Follow-Up Study of the Causes for Discontinuation.

J Pers Med 2021 Jun 8;11(6). Epub 2021 Jun 8.

Sigma Statistical Services, Balmullo KY16 0BD, UK.

(1) Background: Subcutaneous apomorphine infusion (SCAI) is one of the three main treatment options for motor fluctuations in advanced Parkinson's disease (PD). The adherence to SCAI is generally considered to be low due to adverse events and because it is perceived as a treatment option to be used for a limited period only. We evaluated the reasons for discontinuation of SCAI in relation to when patients stopped treatment. (2) Methods: We reviewed the medical records of PD patients treated with SCAI at a single center, capturing patient demographics and the reasons for cessation of SCAI. (3) Results: 101 patients were included in the analysis, with a median time on treatment of 6.34 years. The main reasons for stopping SCAI were adverse events, death, and dissatisfaction with treatment. In the first 6 years of treatment, the predominant side effects leading to discontinuation were somnolence and hallucinations. (4) Conclusions: We suggest that SCAI can be an effective long-term treatment option for advanced PD, but it requires careful patient selection, a high level of communication with the patient and carer, and rigorous monitoring of the effects of treatment and for any adverse events so they can be promptly managed.
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http://dx.doi.org/10.3390/jpm11060525DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8226743PMC
June 2021

Long-term safety and efficacy of apomorphine infusion in Parkinson's disease patients with persistent motor fluctuations: Results of the open-label phase of the TOLEDO study.

Parkinsonism Relat Disord 2021 02 12;83:79-85. Epub 2021 Jan 12.

University College London Institute of Neurology, Queen Square, London, UK. Electronic address:

Introduction: The randomized, double-blind phase (DBP) of the TOLEDO study confirmed the efficacy of apomorphine infusion (APO) in reducing OFF time in PD patients with persistent motor fluctuations despite optimized oral/transdermal therapy. Here we report safety and efficacy results including the 52-week open-label phase (OLP).

Methods: All patients completing the 12-week DBP (including those switching early to open-label treatment) were offered OLP entry. The primary objective was the evaluation of long-term safety of APO.

Results: Eighty-four patients entered the OLP (40 previously on APO, 44 on placebo) and 59 patients (70.2%) completed the study. The safety profile of APO was consistent with experience from extensive clinical use. Common treatment-related adverse events (AEs) were mild or moderate infusion site nodules, somnolence and nausea. Fourteen (16.7%) patients discontinued the OLP due to AEs, those involving >1 patient were infusion site reactions (n = 4) and fatigue (n = 2); hemolytic anemia occurred in one case. Reduction in daily OFF time and improvement in ON time without troublesome dyskinesia were sustained for up to 64 weeks. Pooled data for week 64 (n = 55) showed a mean (SD) change from DBP baseline in daily OFF time of -3.66 (2.72) hours and in ON time without troublesome dyskinesia of 3.31 (3.12) hours. Mean (±SD) daily levodopa-equivalent dose decreased from DBP baseline to week 64 by 543 mg (±674) and levodopa dose by 273 mg (±515).

Conclusions: The safety and efficacy of APO infusion were demonstrated with long-term use for persistent motor fluctuations, allowing substantial reductions in oral PD medication.
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http://dx.doi.org/10.1016/j.parkreldis.2020.12.024DOI Listing
February 2021

N-terminal pro-B-type natriuretic peptide as a prognostic indicator for 30-day mortality following out-of-hospital cardiac arrest: a prospective observational study.

BMC Cardiovasc Disord 2020 08 24;20(1):382. Epub 2020 Aug 24.

Department of Clinical Science, Faculty of Medicine, University of Bergen, Bergen, Norway.

Background: Early risk stratification applying cardiac biomarkers may prove useful in sudden cardiac arrest patients. We investigated the prognostic utility of early-on levels of high sensitivity cardiac troponin-T (hs-cTnT), copeptin and N-terminal pro-B-type natriuretic peptide (NT-proBNP) in patients with out-of-hospital cardiac arrest (OHCA).

Methods: We conducted a prospective observational unicenter study, including patients with OHCA of assumed cardiac origin from the southwestern part of Norway from 2007 until 2010. Blood samples for later measurements were drawn during cardiopulmonary resuscitation or at hospital admission.

Results: A total of 114 patients were included, 37 patients with asystole and 77 patients with VF as first recorded heart rhythm. Forty-four patients (38.6%) survived 30-day follow-up. Neither hs-cTnT (p = 0.49), nor copeptin (p = 0.39) differed between non-survivors and survivors, whereas NT-proBNP was higher in non-survivors (p <  0.001) and significantly associated with 30-days all-cause mortality in univariate analysis, with a hazard ratio (HR) for patients in the highest compared to the lowest quartile of 4.6 (95% confidence interval (CI), 2.1-10.1), p <  0.001. This association was no longer significant in multivariable analysis applying continuous values, [HR 0.96, (95% CI, 0.64-1.43), p = 0.84]. Similar results were obtained by dividing the population by survival at hospital admission, excluding non-return of spontaneous circulation (ROSC) patients on scene [HR 0.93 (95% CI, 0.50-1.73), P = 0.83]. We also noted that NT-proBNP was significantly higher in asystole- as compared to VF-patients, p <  0.001.

Conclusions: Early-on levels of hs-cTnT, copeptin and NT-proBNP did not provide independent prognostic information following OHCA. Prediction was unaffected by excluding on-scene non-ROSC patients in the multivariable analysis.

Trial Registration: ClinicalTrials. gov, NCT02886273 .
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http://dx.doi.org/10.1186/s12872-020-01630-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7445901PMC
August 2020

Association of out of hospital paediatric early warning score with need for hospital admission in a Scottish emergency ambulance population.

Eur J Emerg Med 2020 Dec;27(6):454-460

Department of Anaesthetics and Intensive Care Medicine, Royal Alexandra Hospital, Paisley, UK.

Objective: Physiological derangement, as measured by paediatric early warning score (PEWS) is used to identify children with critical illness at an early point to identify and intervene in children at risk. PEWS has shown some utility as a track and trigger system in hospital and also as a predictor of adverse outcome both in and out of hospital. This study examines the relationship between prehospital observations, aggregated into an eight-point PEWS (Scotland), and hospital admission.

Methods: A retrospective analysis of all patients aged less than 16 transported to hospital by the Scottish Ambulance Service between 2011 and 2015. Data were matched to outcome data regarding hospital admission or discharge and length of stay.

Results: Full data were available for 21 202 paediatric patients, of whom 6340 (29.9%) were admitted to hospital. Prehospital PEWS Scotland was associated with an odds ratio for admission of 1.189 [95% confidence interval (CI): 1.176-1.202; P < 0.001]. The area under receiver operating curve of 0.617 (95% CI: 0.608-0.625; P < 0.001) suggests poorly predictive ability for hospital admission. There was no association between prehospital PEWS Scotland and length of hospital stay.

Conclusion: These data show that a single prehospital PEWS Scotland was a poor predictor of hospital admission for unselected patients in a prehospital population. The decision to admit a child to hospital is not solely based on the physiological derangement of vital signs, and hence physiological-based scoring systems such as PEWS Scotland cannot be used as the sole criteria for hospital admission, from an undifferentiated prehospital population.
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http://dx.doi.org/10.1097/MEJ.0000000000000725DOI Listing
December 2020

Development of a high throughput and low cost model for the study of semi-dry biofilms.

Biofouling 2020 04 22;36(4):403-415. Epub 2020 May 22.

Institute of Healthcare Policy and Practice, School of Health and Life Sciences, University of the West of Scotland, Paisley, UK.

The persistence of microorganisms as biofilms on dry surfaces resistant to the usual terminal cleaning methods may pose an additional risk of transmission of infections. In this study, the Centre for Disease Control (CDC) dry biofilm model (DBM) was adapted into a microtiter plate format (Model 1) and replicated to create a novel model that replicates conditions commonly encountered in the healthcare environment (Model 2). Biofilms of grown in the two models were comparable to the biofilms of the CDC DBM in terms of recovered log CFU well. Assessment of the antimicrobial tolerance of biofilms grown in the two models showed Model 2 a better model for biofilm formation. Confirmation of the biofilms' phenotype with an extracellular matrix deficient suggested stress tolerance through a non-matrix defined mechanism in microorganisms. This study highlights the importance of conditions maintained in bacterial growth as they affect biofilm phenotype and behaviour.
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http://dx.doi.org/10.1080/08927014.2020.1766030DOI Listing
April 2020

Superior performance of National Early Warning Score compared with quick Sepsis-related Organ Failure Assessment Score in predicting adverse outcomes: a retrospective observational study of patients in the prehospital setting.

Eur J Emerg Med 2019 Dec;26(6):433-439

Anaesthetic and Critical Care Department, Queen Elizabeth University Hospital.

Background: Early intervention and response to deranged physiological parameters in the critically ill patient improve outcomes. A National Early Warning Score (NEWS) based on physiological observations has been developed for use throughout the National Health Service in the UK. The quick Sepsis-related Organ Failure Assessment Score (qSOFA) was developed as a simple bedside criterion to identify adult patients outwith the ICU with suspected infection who are likely to have a prolonged ICU stay or die in hospital. We aim to compare the ability of NEWS and qSOFA to predict adverse outcomes in a prehospital population.

Patients And Methods: All clinical observations taken by emergency ambulance crews transporting patients to a single hospital were collated along with information relating to mortality over a 2-month period. The performance of the NEWS and qSOFA in identifying the endpoints of 30-day mortality, ICU admission and a combined endpoint of 48 h. ICU admission or 30-day mortality was analysed.

Results: Complete data were available for 1713 patients. For the primary outcome of ICU admission within 48 h or 30-day mortality, the odds ratio for a qSOFA score of 3 compared with 0 was 124.1 [95% confidence interval (CI): 13.5-1137.7] and the odds ratio for a high NEWS category, compared with the low NEWS category was 9.82 (95% CI: 5.74-16.81). Comparison of qSOFA and NEWS performance was assessed using receiver operating characteristic curves. The area under the receiver operating characteristic curve for the primary outcome for qSOFA was 0.679 (95% CI: 0.624-0.733), for NEWS category was 0.707 (95% CI: 0.654-0.761) and for NEWS total score was 0.740 (95% CI: 0.685-0.795). Comparison of the receiver operating characteristic curves between NEWS total score and qSOFA using DeLong's test showed NEWS total score to be superior to qSOFA at predicting combined ICU admission within 48 h of presentation or 30-day mortality (P = 0.011).

Conclusion: Our study shows qSOFA can identify patients at risk of adverse outcomes in the prehospital setting. However, NEWS is superior to qSOFA in a prehospital environment at identifying patients at risk of adverse outcomes.
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http://dx.doi.org/10.1097/MEJ.0000000000000589DOI Listing
December 2019

The relationship between frailty, functional dependence, and healthcare needs among community-dwelling people with moderate to severe dementia.

Health Soc Care Community 2019 May 7;27(3):642-653. Epub 2018 Nov 7.

University of Aveiro - Campus Universitário de Santiago, Aveiro, Portugal.

This paper examines the healthcare needs of community-dwelling older people living in Porto, Portugal, diagnosed with moderate or severe dementia, linked to functional dependency, cognitive decline, limitations in the activities of daily life, and frailty levels. A sample of 83 participants was recruited. Data were collected between 2013 and 2017. A sociodemographic questionnaire, the Clinical Dementia Rating (CDR), the Barthel Index (BI), the Lawton and Brody Instrumental Activities of Daily Living (IADL) Scale, and the Edmonton Frail Scale (EFS) were used. A set of 26 healthcare needs was defined to support the assessment. The Pearson chi-square or Fisher's exact test (as appropriate) was used to examine the association of the needs (unmet and met) with the levels of dementia and frailty. Participants were diagnosed previously with moderate or severe dementia and benefited from a structured home-care program. There was a high number rated as "severe dementia," "fully dependent," "severely or fully dependent in the activities of daily living (ADL)," and "severe frailty." There were statistically significant differences among needs identified in people with moderate or severe dementia and moderate or severe frailty. The most prevalent healthcare needs in the sample were food preparation, medication/taking pills, looking after their home, toilet use, sensory problems, communication/interaction, bladder, bowels, eating and drinking, memory, sleeping, and falls prevention. In particular, the study identifies a set of needs that are present simultaneously in both frailty and dementia stages. This study underlines that despite well-structured home-care programs for people with dementia, unmet health needs remain. Timely healthcare needs assessment may help professionals to avoid fragmented care and to tailor quality-integrated interventions, including the emotional and psychological balance of the caregiver.
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http://dx.doi.org/10.1111/hsc.12678DOI Listing
May 2019

RANIBIZUMAB 0.5 MG TREATMENT IN ADOLESCENTS WITH CHOROIDAL NEOVASCULARIZATION: SUBGROUP ANALYSIS DATA FROM THE MINERVA STUDY.

Retin Cases Brief Rep 2021 Jul;15(4):348-355

Sigma Statistical Services, Balmullo, St Andrews, Scotland, United Kingdom; and.

Purpose: To evaluate the efficacy and safety of ranibizumab 0.5 mg in adolescent patients with any choroidal neovascularization etiology enrolled in the 12-month MINERVA study.

Methods: In the open-label, non-randomized study arm, ranibizumab 0.5 mg was administered to five adolescents (aged 13-17 years). The findings were assessed descriptively as individual case reports at Month 12. Best-corrected visual acuity changes, central subfield thickness, treatment exposure, and safety were described over 12 months.

Results: Baseline choroidal neovascularization etiologies of the study eye included choroidal neovascularization secondary to Best disease (n = 2), idiopathic chorioretinopathy (n = 2), and optic disk drusen (n = 1). At Months 2, 6, and 12, the observed mean best-corrected visual acuity changes in the study eye from baseline were +9.2, +16.6, and +16.6 letters, respectively, and the observed mean central subfield thickness change from baseline was -31.4, -87.6, and -116.4 μm, respectively. Adolescent patients received a mean of three (range, 2-5) ranibizumab injections in the study eye. No adverse events or serious adverse events related to ranibizumab were reported.

Conclusion: Ranibizumab 0.5 mg treatment was beneficial in improving visual acuity and stabilizing or reducing central subfield thickness in five adolescents with differing choroidal neovascularization etiologies requiring infrequent injection. No new safety findings were observed over 12 months.
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http://dx.doi.org/10.1097/ICB.0000000000000825DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8219082PMC
July 2021

Apomorphine subcutaneous infusion in patients with Parkinson's disease with persistent motor fluctuations (TOLEDO): a multicentre, double-blind, randomised, placebo-controlled trial.

Lancet Neurol 2018 09 25;17(9):749-759. Epub 2018 Jul 25.

University College London Institute of Neurology, London, UK.

Background: Subcutaneous apomorphine infusion is a clinically established therapy for patients with Parkinson's disease with motor fluctuations not optimally controlled by oral medication. Open-label studies have shown that apomorphine infusion is effective in reducing off time (periods when antiparkinsonian drugs have no effect), dyskinesias, and levodopa dose, but confirmatory evidence from double-blind, controlled studies is lacking. We aimed to investigate the efficacy and safety of apomorphine infusion compared with placebo in patients with Parkinson's disease with persistent motor fluctuations despite optimised oral or transdermal treatment.

Methods: In this randomised, placebo-controlled, double-blind, multicentre trial, we enrolled patients at 23 European hospitals who had been diagnosed with Parkinson's disease more than 3 years previously and had motor fluctuations not adequately controlled by medical treatment. Patients were randomly assigned (1:1) with a computer-generated randomisation code, stratified by site, to receive 3-8 mg/h apomorphine or placebo saline infusion during waking hours (16 h a day [range 14-18 was acceptable]) for 12 weeks. The flow rate of the study drug and other oral medications could be adjusted during the first 4 weeks on the basis of individual efficacy and tolerability, after which patients entered an 8-week maintenance period. The primary endpoint was the absolute change in daily off time based on patient's diaries, and was assessed in the full analysis set, which was defined as all patients who received at least one dose of allocated study drug and had efficacy data available at any timepoint post-baseline. Safety was assessed in all patients who received at least one dose of apomorphine or placebo. All study participants and investigators were masked to treatment assignment. Both the 12-week double-blind phase and the 52-week open-label phase of this study are now complete; this paper reports results for the double-blind phase only. This study is registered with ClinicalTrials.gov (NCT02006121).

Findings: Between March 3, 2014, and March 1, 2016, 128 patients were screened for eligibility and 107 were randomly assigned, of whom 106 were included in the full analysis set (n=53 in both groups). Apomorphine infusion (mean final dose 4·68 mg/h [SD 1·50]) significantly reduced off time compared with placebo (-2·47 h per day [SD 3·70] in the apomorphine group vs -0·58 h per day [2·80] in the placebo group; difference -1·89 h per day, 95% CI -3·16 to -0·62; p=0·0025). Apomorphine was well tolerated without any unexpected safety signals. Six patients in the apomorphine group withdrew from the study because of treatment-related adverse events.

Interpretation: Apomorphine infusion results in a clinically meaningful reduction in off time in patients with Parkinson's disease with persistent motor fluctuations despite optimised oral or transdermal therapy.

Funding: Britannia Pharmaceuticals.
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http://dx.doi.org/10.1016/S1474-4422(18)30239-4DOI Listing
September 2018

Initial Phase NT-proBNP, but Not Copeptin and High-Sensitivity Cardiac Troponin-T Yielded Diagnostic and Prognostic Information in Addition to Clinical Assessment of Out-of-Hospital Cardiac Arrest Patients With Documented Ventricular Fibrillation.

Front Cardiovasc Med 2018 7;5:44. Epub 2018 Jun 7.

Division of Cardiology, Stavanger University Hospital, Stavanger, Norway.

Aim: Sudden cardiac arrest (SCA) secondary to ventricular fibrillation (VF) may be due to different cardiac conditions. We investigated whether copeptin, hs-cTnT and NT-proBNP in addition to clinical assessment may help to identify the etiology of SCA and yield prognostic information.

Methods And Results: EDTA-blood was collected prior to or at hospital admission from patients with SCA of assumed cardiac origin. Clinical data were obtained from hospital records. VF was the primary heart rhythm in 77 patients who initially were divided into 2 groups based on whether they had an ischemic or non-ischemic mechanism as the most likely cause of SCA. They were further divided into 4 groups according to whether or not they had a history of previous heart disease. The patients were categorized by baseline clinical information, ECG, echocardiography and coronary angiography; Group 1 (n = 43): SCA with first AMI, Group 2 (n = 10): SCA with AMI and previous MI, Group 3 (n = 3): SCA without AMI and without former heart disease, Group 4 (n = 18): SCA without AMI and with known heart disease. Copeptin and hs-cTNT did not differ between patient groups, whereas NT-proBNP was significantly higher in patients with established heart disease without AMI and differed between non-AMI and AMI. Furthermore, NT-proBNP was significantly elevated in non-survivors as compared to survivors.

Conclusion: NT-proBNP provided both diagnostic and prognostic information in blood samples collected close to out-of-hospital resuscitation of VF patients, whereas copeptin and hs-cTnT failed to do so.

Clinical Trial Registration: ClinicalTrials.gov, NCT02886273.
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http://dx.doi.org/10.3389/fcvm.2018.00044DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6001003PMC
June 2018

The prognostic utility of dihomo-gamma-linolenic acid (DGLA) in patients with acute coronary heart disease.

Int J Cardiol 2017 Dec 29;249:12-17. Epub 2017 Sep 29.

Department of Medicine, Stavanger University Hospital, 4068 Stavanger, Norway; Department of Clinical Science, University of Bergen, 5020 Bergen, Norway.

Background: We previously investigated the prognostic utility of red blood cell (RBC) n-3 fatty acids (FAs) in survivors of an acute myocardial syndrome (ACS) but found no relationship with all-cause mortality and cardiac death or MI after two years. Here we extend our follow-up to 7years, focusing on the potential predictive power of RBC n-6 FAs.

Methods: We included 398 ACS patients presenting with increased troponin-T (TnT) levels for whom baseline RBC FA data were available. Cox regression analysis was used to relate the risk of future events to RBC n-6 FA levels, both continuously and by quartile.

Results: At 7-year follow-up, 183 (46.0%) had died, 128 (32.2%) had experienced another MI and 24 (6.0%) had had a stroke. Death or MI occurred in 227 patients (57.0%); and death, MI or stroke in 235 patients (59.0%). In a multivariable Cox regression model for total death, the hazard ratio (HR) in the highest as compared to the lowest quartile of dihomo-γ-linolenic acid (DGLA) was 0.55 [95% confidence interval (CI), 0.35-0.88, p=0.012, for death or MI [HR 0.62 (95% CI, 0.41-0.94), p=0.025], and for the fully combined endpoint [HR 0.57 (95% CI, 0.38-0.86), p=0.006]. Similar results were found in the per 1-SD analysis. No other RBC n-6 FAs significantly predicted these outcomes in multivariable models.

Conclusion: RBC DGLA levels had significant independent prognostic value in post-ACS patients. These findings need confirmation, and the possible biochemical pathways by which higher DGLA membrane levels may be cardioprotective should be explored.
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http://dx.doi.org/10.1016/j.ijcard.2017.09.202DOI Listing
December 2017

Vitamin D Uptake in Patients Treated with a High-Dosed Purified Omega-3 Compound in a Randomized Clinical Trial Following an Acute Myocardial Infarction.

Front Cardiovasc Med 2017 24;4:41. Epub 2017 Jul 24.

Department of Cardiology, Stavanger University Hospital, Stavanger, Norway.

Background: Fish is the natural dietary source of vitamin D. Reports on the influence of purified omega-3 fatty acids on its uptake are scarce.

Objectives: We investigated the impact of a purified high-dose omega-3 compound compared to corn oil on 25-hydroxyvitamin D [25(OH)D] levels following an acute myocardial infarction.

Methods: 228 patients were randomized 1:1 to receive a daily dose of either 4 g omega-3 (OMACOR) or an equal dose of corn oil, administered double-blindly for 12 months. Total omega-3 and omega-6 measurements were available in 40 randomly picked patients.

Results: There was no significant intergroup difference in 25(OH)D changes at 12 months follow-up ( = 0.12), but there was a minor statistical significant intragroup increase in 25(OH)D in both intervention arms ( < 0.001 for n-3 polyunsaturated fatty acids and  = 0.013 for corn oil, respectively). A positive correlation was noted between 25(OH)D and omega-3 prior to inclusion;  = 0.418,  = 0.007, attenuated at 12 months by purified omega-3 intervention;  = 0.021,  = 0.93. No positive correlation was observed between omega-6 and 25(OH)D.

Conclusion: Long-term treatment with a high dose of purified omega-3 as compared to corn oil did not improve serum concentrations of vitamin D.

Clinical Trial Registration: ClinicalTrials.gov, Identifier: NCT01422317.
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http://dx.doi.org/10.3389/fcvm.2017.00041DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5522877PMC
July 2017

EFFICACY AND SAFETY OF RANIBIZUMAB FOR THE TREATMENT OF CHOROIDAL NEOVASCULARIZATION DUE TO UNCOMMON CAUSE: Twelve-Month Results of the MINERVA Study.

Retina 2018 08;38(8):1464-1477

NIHR Biomedical Centre for Research in Ophthalmology, Moorfields Eye Hospital, London, United Kingdom.

Purpose: To evaluate the efficacy and safety of ranibizumab 0.5 mg in adult patients with choroidal neovascularization because of an uncommon cause enrolled in the 12-month MINERVA study.

Methods: In this Phase III, double-masked study, adult (≥18 years) patients (N = 178) were randomized 2:1 to receive either ranibizumab (n = 119) or sham (n = 59) at baseline and, if needed, at Month 1 and open-label individualized ranibizumab from Month 2. Best-corrected visual acuity change from baseline to Month 2 (primary endpoint) and Month 12, treatment exposure, and safety over 12 months were reported. Subgroup analysis was conducted on five predefined choroidal neovascularization etiologies (angioid streak, postinflammatory, central serous chorioretinopathy, idiopathic, and miscellaneous).

Results: Ranibizumab showed superior efficacy versus sham from baseline to Month 2 (adjusted least-squares mean best-corrected visual acuity: +9.5 vs. -0.4 letters; P < 0.001). At Month 12, the mean best-corrected visual acuity change was +11.0 letters (ranibizumab) and +9.3 letters (sham). Across the 5 subgroups, the treatment effect ranged from +5.0 to +14.6 letters. The mean number of ranibizumab injections was 5.8 (ranibizumab arm) with no new ocular or nonocular adverse events.

Conclusion: Ranibizumab 0.5 mg resulted in clinically significant treatment effect versus sham at Month 2. Overall, ranibizumab was effective in treating choroidal neovascularization of various etiologies with no new safety findings.
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http://dx.doi.org/10.1097/IAE.0000000000001744DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6086222PMC
August 2018

Erratum to: The accuracy and timeliness of a Point Of Care lactate measurement in patients with Sepsis.

Scand J Trauma Resusc Emerg Med 2016 Mar 31;24:41. Epub 2016 Mar 31.

Institute of Healthcare Policy and Practice, School of Health, Nursing and Midwifery, University of the West of Scotland, Paisley, UK.

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http://dx.doi.org/10.1186/s13049-016-0227-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4818480PMC
March 2016

Review and comparison of methodologies for indirect comparison of clinical trial results: an illustration with ranibizumab and aflibercept.

Expert Rev Pharmacoecon Outcomes Res 2016 Dec 25;16(6):793-801. Epub 2016 Mar 25.

c Centre Ophtalmologique d'Imagerie et de Laser , Paris , France.

Aim: To review and compare methods for indirect comparison of aflibercept and ranibizumab in patients with diabetic macular edema.

Methods: Post-stratification, inverse probability weighting based on simulated data, weight optimization, and regression model techniques were used to compare pooled individual patient-level data from the RESTORE and RESPOND (ranibizumab 0.5 mg as needed after 3 initial monthly doses) studies with summary-level data from the VIVID and VISTA (aflibercept 2.0 mg every 8 weeks after 5 initial monthly doses, 2q8) studies. The impact of adjusting for up to two baseline characteristics was assessed.

Results: All methods provided similar results. After adjustment for baseline best-corrected visual acuity and central retinal thickness, no statistically significant difference in average gain in baseline best-corrected visual acuity from baseline at month 12 was found between ranibizumab 0.5 mg and aflibercept 2q8.

Conclusions: Weight optimization and regression methods are useful options to adjust for more than one baseline characteristic.
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http://dx.doi.org/10.1586/14737167.2016.1165609DOI Listing
December 2016

Suggested Cut-Off Values for Vitamin D as a Risk Marker for Total and Cardiac Death in Patients with Suspected Acute Coronary Syndrome.

Front Cardiovasc Med 2016 26;3. Epub 2016 Feb 26.

Department of Cardiology, Stavanger University Hospital, Stavanger, Norway; Department of Clinical Science, University of Bergen, Bergen, Norway.

Background: Several studies have demonstrated an association between low vitamin D levels and cardiovascular risk. Vitamin D cut-off levels are still under debate.

Objectives: To assess two cut-off levels, 40 and 70 nmol/L, respectively, for vitamin D measured as 25-hydroxyvitamin D in chest pain patients with suspected acute coronary syndrome.

Methods: We investigated 1853 patients from coastal-Norway and inland Northern-Argentina. A similar database was used for pooling of data. Two-year follow-up data including all-cause mortality, cardiac death, and sudden cardiac death in the total patient population were analyzed, applying univariate and multivariable analysis.

Results: Two hundred fifty-five patients with known vitamin D concentrations died. In the multivariable analysis, there was a decrease in total mortality above a cut-off level of 40 nmol/L and a decrease in cardiac death above a cut-off level of 70 nmol/L [HRs of 0.66 (95% CI, 0.50-0.88), p = 0.004 and 0.46 (95% CI, 0.22-0.94), p = 0.034, respectively].

Conclusion: Vitamin D cut-off levels of 40 and 70 nmol/L were related to total mortality and cardiac death, respectively.
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http://dx.doi.org/10.3389/fcvm.2016.00004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4767896PMC
March 2016

Borderline Values of Troponin-T and High Sensitivity C-Reactive Protein Did Not Predict 2-Year Mortality in TnT Positive Chest-Pain Patients, Whereas Brain Natriuretic Peptide Did.

Front Cardiovasc Med 2015 8;2:16. Epub 2015 Apr 8.

Department of Research, Stavanger University Hospital , Stavanger , Norway ; Department of Clinical Medicine, University of Bergen , Bergen , Norway.

Background: Troponin-T (TnT), high-sensitive C-reactive protein (hsCRP), and Brain Natriuretic Peptide (BNP) have been shown to be independent prognostic indicators of total and cardiac death during short- and long-term follow-up.

Methods: We investigated prospectively the prognostic value of admission samples of TnT, hsCRP, and BNP in 871 chest-pain patients from South-Western Norway and 982 patients from Northern Argentina, based on a similar protocol and database setup. Follow-up was 2 years for the pooled population. The prognostic value of the selected biomarkers was investigated in quartiles of 239 patients with TnT values greater than 0.01 and up to and including 0.1 ng/mL, with continuous TnT as a potential confounder.

Results: After 24 months, 69 patients had died, of whom 38 died from cardiac causes. In the selected range of TnT, this biomarker was not significantly different between patients who died and survived (mean 0.0452 and 0.0457, p = 0.887). The BNP levels were significantly higher among patients dying than in long-term survivors [340 (142-656) versus 157 (58-367) pg/mL (median, 25 and 75% percentiles), p < 0.001]. In a multivariable Cox regression model for death within 2 years, the hazard ratio (HR) for BNP in the highest quartile (Q4) as compared to the lowest (Q1) was significantly related to total mortality [HR 2.84 (95% confidence interval (CI), 1.13-7.17)], p = 0.027, in addition to age (p ≤ 0.001) and hypercholesterolemia (p = 0.043). For cardiac death, the HR for BNP was 5.18 (95% CI, 1.06-25.3), p = 0.042. Several other variables (age, congestive heart failure, ST elevation myocardial infarction, and study country) were also significantly related to cardiac death. In a multivariable Cox regression model, hsCRP rendered no significant prognostic information for all-cause mortality (p = 0.089) or for cardiac mortality (p = 0.524).

Conclusion: In patients with borderline TnT values (greater than 0.01 and up to and including 0.1 ng/mL), this biomarker as well as hsCRP did not render prognostic information, whereas BNP was found to be a strong prognostic indicator of 2-year total and cardiac mortality.
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http://dx.doi.org/10.3389/fcvm.2015.00016DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4671363PMC
December 2015

Long-term prognostic utility of pentraxin 3 and D-dimer as compared to high-sensitivity C-reactive protein and B-type natriuretic peptide in suspected acute coronary syndrome.

Eur J Prev Cardiol 2016 07 3;23(11):1130-40. Epub 2015 Dec 3.

Department of Clinical Science, University of Bergen, Bergen, Norway Department of Cardiology, Stavanger University Hospital, Stavanger, Norway.

Background: Vascular inflammation plays a key role in the development of atherosclerosis and acute coronary syndrome (ACS), and pentraxin 3 (PTX3) is one of several novel, promising markers of inflammation. In addition, D-dimer might serve as a marker of thrombogenesis and a hypercoagulable state following plaque rupture. The present study assesses the prognostic utility of these two biomarkers as compared to high-sensitivity C-reactive protein (hsCRP) and B-type natriuretic peptide (BNP), in addition to conventional clinical risk factors for coronary heart disease in patients with suspected ACS.

Methods: Chest pain patients with suspected ACS (n = 871) were consecutively included in a prospective, observational study with a follow-up time of 84 months.

Results: At 7-year follow-up, 332 patients had died and 203 had suffered an adverse troponin T-positive, non-fatal cardiac event. In the multivariate analysis, levels of PTX3 above 5.88 ng/mL (median) and D-dimer above 436 µg/L (lower limit upper quartile) independently predicted mortality (HR 1.60 [95% CI 1.10-2.33]; p = 0.014 and HR 1.83 [95% CI 1.20-2.78]; p = 0.005, respectively). Also, BNP levels above 310.75 pg/mL (lower limit upper quartile) (HR 2.16 [95% CI 1.37-3.42]; p = 0.001), but not hsCRP, independently predicted mortality. Only hsCRP and BNP also predicted future myocardial infarction (HR 1.59 [95% CI 1.05-2.40]; p = 0.029 and HR 1.91 [95% CI 1.10-3.31]; p = 0.021, respectively).

Conclusion: High levels of PTX3, D-dimer and BNP were found to be independent, long-term predictors of all-cause mortality in chest pain patients with a suspected ACS. hsCRP and BNP also predicted future myocardial infarction.
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http://dx.doi.org/10.1177/2047487315619733DOI Listing
July 2016

The accuracy and timeliness of a Point Of Care lactate measurement in patients with Sepsis.

Scand J Trauma Resusc Emerg Med 2015 Sep 17;23:68. Epub 2015 Sep 17.

Institute of Healthcare Policy and Practice, School of Health, Nursing and Midwifery, University of the West of Scotland, Paisley, UK.

Background: The aims of this study were to a) compare the lactate measurement of a Point of Care (POC) handheld device to near patient blood gas analysers, and b) determine the differential reporting times between the analysers.

Methods: A two-staged study; method comparison and prospective observational stages, was conducted. For the first stage, blood samples were analysed on the i-STAT handheld device and the near patient blood gas analysers (GEM 4000 and OMNI S). Results were compared using Pearson correlation coefficient and Bland-Altman tests. For the second stage, we examined the differential reporting times of the POC device compared to the near patient blood gas analysers in two Scottish hospitals. Differential reporting times were assessed using Mann-Whitney test and descriptive statistics were reported with quartiles.

Results: Highly significant Pearson correlation coefficients (0.999 and 0.993 respectively) were found between i-STAT and GEM 4000 and OMNI S. The Bland-Altman agreement method showed bias values of -0.03 and -0.24, between i-STAT and GEM 4000 and OMNI S respectively. Median time from blood draw to i-STAT lactate results was 5 min (Q1-Q3 5-7). Median time from blood draw to GEM 4000 lactate results was 10 min (Q1-Q3 7.75-13). Median time from blood draw to OMNIS lactate results was 11 min (Q1-Q3 8-22). The i-STAT was significantly quicker than both the GEM 4000 and the OMNIS (each p-value < 0.001). In addition, 18 of our study samples were sent to the central laboratory for analysis due to a defect in the lactate module of OMNI S. The median time for these samples from blood draw to availability of the central laboratory results at the clinical area was 133 min.

Conclusions: The POC handheld device produced accurate, efficient and timely lactate measurements with the potential to influence clinical decision making sooner.
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http://dx.doi.org/10.1186/s13049-015-0151-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4573294PMC
September 2015

Prognostic utility of vitamin D in acute coronary syndrome patients in coastal Norway.

Dis Markers 2015 5;2015:283178. Epub 2015 Feb 5.

Department of Cardiology, Stavanger University Hospital, Stavanger, Norway ; Department of Clinical Science, University of Bergen, Bergen, Norway.

Background: An inverse relationship between cardiovascular risk and levels of vitamin D and omega-3 index may exist.

Objectives: To evaluate the prognostic utility of serum 25-hydroxyvitamin D [25(OH)D] in 871 patients with suspected acute coronary syndrome (ACS) and to assess the seasonal correlation between 25(OH)D and the omega-3 index in 456 ACS patients from southwestern Norway.

Results: In the univariate analysis the hazard ratio (HR) at 2-year follow-up for all-cause mortality in the highest as compared to the lowest quartile of 25(OH)D in the total population was 0.61 (95% confidence interval (CI), 0.37-1.00), P = 0.050. At 7-year follow-up, the corresponding HR for all-cause mortality was 0.66 (95% CI, 0.49-0.90), P = 0.008, and for females alone 0.51 (95% CI, 0.32-0.83), P = 0.006. Quartile survival did not differ in the multivariable analysis, whereas 25(OH)D < 40 nM (<16 ng/mL) was found to be independently related to mortality. Seasonal differences in 25(OH)D, but not for the omega-3 index, were noted, and the two biomarkers were positively correlated, especially during winter-spring; Pearson's correlation coefficient was 0.358, P < 0.001.

Conclusion: Vitamin D levels are related to survival, especially in females, and correlate with the omega-3 index.
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http://dx.doi.org/10.1155/2015/283178DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4334438PMC
October 2015

Vitamin d predicts all-cause and cardiac mortality in females with suspected acute coronary syndrome: a comparison with brain natriuretic Peptide and high-sensitivity C-reactive protein.

Cardiol Res Pract 2013 17;2013:398034. Epub 2013 Nov 17.

Department of Cardiology, Stavanger University Hospital, 4068 Stavanger, Norway ; Cardiology Research Institute, Catholic University of Salta, A4400ANG Salta, Argentina.

Vitamin D may not only reflect disease but may also serve as a prognostic indicator. Our aim was to assess the gender-specific utility of vitamin D measured as 25-hydroxy-vitamin D [25(OH)D] to predict all-cause and cardiac death in patients with suspected acute coronary syndrome (ACS) and to compare its prognostic utility to brain natriuretic peptide (BNP) and high-sensitivity C-reactive protein (hsCRP). Blood samples were harvested on admission in 982 patients. Forty percent were women (65.9 ± 12.6 years). Mortality was evaluated in quartiles of 25(OH)D, BNP, and hsCRP, respectively, during a 5-year follow-up, applying univariate and multivariate analyses. One hundred and seventy-three patients died; 78 were women. In 92 patients (37 women), death was defined as cardiac. In women, the univariate hazard ratio (HR) for total death of 25(OH)D in Quartile (Q) 2 versus Q1, Q3 versus Q1, and Q4 versus Q1 was 0.55 (95% CI 0.33-0.93), 0.29 (95% CI 0.15-0.55), and 0.13 (95% CI 0.06-0.32), respectively. In females, it was an independent predictor of total and cardiac death, whereas BNP and hsCRP were less gender-specific. No gender differences in 25(OH)D were noted in a reference material. Accordingly, vitamin D independently predicts mortality in females with suspected ACS.
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http://dx.doi.org/10.1155/2013/398034DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3855936PMC
December 2013

Socioeconomic assessment and impact of social security on outcome in patients admitted with suspected coronary chest pain in the city of salta, Argentina.

Cardiol Res Pract 2013 29;2013:807249. Epub 2013 May 29.

Department of Cardiology, Stavanger University Hospital, Postboks 8100, 4068 Stavanger, Norway ; Institute of Medicine, University of Bergen, Postboks 7804, 5020 Bergen, Norway ; Cardiology Research Institute, Catholic University of Salta, España 311, A4400ANG Salta, Argentina.

Low socioeconomic status is associated with increased mortality from coronary heart disease. We assessed total mortality, cardiac death, and sudden cardiac death (SCD) in relation to socioeconomic class and social security in 982 patients consecutively admitted with suspected coronary chest pain, living in the city of Salta, northern Argentina. Patients were divided into three socioeconomic classes based on monthly income, residential area, and insurance coverage. Five-year follow-up data were analyzed accordingly, applying univariate and multivariate analyses. At follow-up, 173 patients (17.6%) had died. In 92 patients (9.4%) death was defined as cardiac, of whom 59 patients (6.0%) were characterized as SCD. In the multivariate analysis, the hazard ratios (HRs) for all-cause and cardiac mortality in the highest as compared to the lowest socioeconomic class were 0.42 (95% confidence interval (CI), 0.22-0.80), P = 0.008, and 0.39 (95% CI, 0.15-0.99), P = 0.047, respectively. Comparing patients in the upper socioeconomic class to patients without healthcare coverage, HRs were 0.46 (95% CI, 0.23-0.94), P = 0.032, and 0.37 (95% CI, 0.14-1.01), P = 0.054, respectively. In conclusion, survival was mainly tied to socioeconomic inequalities in this population, and the impact of a social security program needs further attention.
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http://dx.doi.org/10.1155/2013/807249DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3681265PMC
July 2013

Long-term prognostic utility of PAPP-A and calprotectin in suspected acute coronary syndrome.

Scand Cardiovasc J 2013 Apr 13;47(2):88-97. Epub 2013 Feb 13.

Department of Medicine, Stavanger University Hospital, Stavanger, Norway.

Background: Vascular inflammation plays a key role in the development of acute coronary syndrome (ACS). Pregnancy-associated plasma protein A (PAPP-A) and calprotectin are two of several novel promising markers of inflammation. The present study evaluates the prognostic utility of these two biomarkers in patients with suspected ACS.

Methods: Chest pain patients with suspected ACS (N = 871) were consecutively included in a prospective, observational study with a mean follow-up time of 84 months. Blood samples were drawn at admission, prior to treatment with heparin.

Results: Total mortality was 38.9%. In univariate analyses, high PAPP-A levels were associated with significant increased mortality. The hazard ratio [HR] in quartile (Q) 3 and Q4 were 1.57 (95% confidence interval (CI), 1.14-2.18), p = 0.006, and 1.41 [95% CI 1.02-1.97], p = 0.040, respectively, as compared to Q1. Calprotectin in the upper quartile (Q4) was associated with total mortality [HR1.94 (95% CI 1.42-2.66)], p = < 0.001, the combined endpoint of death or recurrent myocardial infarction (MI) [HR 1.68 (95% CI 1.26-2.24), p = < 0.001], and recurrent MI [HR 1.60 (95% CI 1.06-2.41); p = 0.024]. However, neither PAPP-A nor calprotectin was found to be an independent predictor of future adverse events.

Conclusion: In this study, high levels of PAPP-A and calprotectin were associated with adverse clinical outcome in chest pain patients with clinically suspected ACS. However, neither of the two biomarkers was an independent predictor of long-term prognosis.
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http://dx.doi.org/10.3109/14017431.2013.764571DOI Listing
April 2013

Serum 25(OH)D is a 2-year predictor of all-cause mortality, cardiac death and sudden cardiac death in chest pain patients from Northern Argentina.

PLoS One 2012 6;7(9):e43228. Epub 2012 Sep 6.

Department of Cardiology, Stavanger University Hospital, Stavanger, Norway.

Background: Several studies have shown an association between vitamin D deficiency and cardiovascular risk. Vitamin D status is assessed by determination of 25-hydroxyvitamin D [25(OH)D] in serum.

Methods: We assessed the prognostic utility of 25(OH)D in 982 chest-pain patients with suspected acute coronary syndrome (ACS) from Salta, Northern Argentina. 2-year follow-up data including all-cause mortality, cardiac death and sudden cardiac death were analyzed in quartiles of 25(OH)D, applying univariate and multivariate analysis.

Results: There were statistically significant changes in seasonal 25(OH)D levels. At follow-up, 119 patients had died. The mean 25(OH)D levels were significantly lower among patients dying than in long-term survivors, both in the total population and in patients with a troponin T (TnT) release (n = 388). When comparing 25(OH)D in the highest quartile to the lowest quartile in a multivariable Cox regression model for all-cause mortality, the hazard ratio (HR) for cardiac death and sudden cardiac death in the total population was 0.37 (95% CI, 0.19-0.73), p = 0.004, 0.23 (95% CI, 0.08-0.67), p = 0.007, and 0.32 (95% CI, 0.11-0.94), p = 0.038, respectively. In patients with TnT release, the respective HR was 0.24 (95% CI, 0.10-0.54), p = 0.001, 0.18 (95% CI, 0.05-0.60), p = 0.006 and 0.25 (95% CI, 0.07-0.89), p = 0.033. 25(OH)D had no prognostic value in patients with no TnT release.

Conclusion: Vitamin D was shown to be a useful biomarker for prediction of mortality when obtained at admission in chest pain patients with suspected ACS.

Trial Registration: ClinicalTrials.gov NCT01377402.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0043228PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3435385PMC
May 2013

B-type natriuretic peptide and high sensitive C-reactive protein predict 2-year all cause mortality in chest pain patients: a prospective observational study from Salta, Argentina.

BMC Cardiovasc Disord 2011 Sep 29;11:57. Epub 2011 Sep 29.

Department of Cardiology, Stavanger University Hospital, Stavanger, Norway.

Background: Several mechanisms are involved in the pathophysiology of the Acute Coronary Syndrome (ACS). We have addressed whether B-type natriuretic peptide (BNP) and high-sensitive C-reactive protein (hsCRP) in admission samples may improve risk stratification in chest pain patients with suspected ACS.

Methods: We included 982 patients consecutively admitted with chest pain and suspected ACS at nine hospitals in Salta, Northern Argentina. Total and cardiac mortality were recorded during a 2-year follow up period. Patients were divided into quartiles according to BNP and hsCRP levels, respectively, and inter quartile differences in mortality were statistically evaluated applying univariate and multivariate analyses.

Results: 119 patients died, and the BNP and hsCRP levels were significantly higher among these patients than in survivors. In a multivariable Cox regression model for total death and cardiac death in all patients, the hazard ratio (HR) in the highest quartile (Q4) as compared to the lowest quartile (Q1) of BNP was 2.32 (95% confidence interval (CI), 1.24-4.35), p = 0.009 and 3.34 (95% CI, 1.26-8.85), p = 0.015, respectively. In the TnT positive patients (TnT > 0.01 ng/mL), the HR for total death and cardiac death in Q4 as compared to Q1 was 2.12 (95% CI, 1.07-4.18), p = 0.031 and 3.42 (95% CI, 1.13-10.32), p = 0.029, respectively.The HR for total death for hsCRP in Q4 as compared to Q1 was 1.97 (95% CI, 1.17-3.32), p = 0.011, but this biomarker did not predict cardiac death (p = 0.21). No prognostic impact of these two biomarkers was found in the TnT negative patients.

Conclusion: BNP and hsCRP may act as clinically useful biomarkers when obtained at admission in a population with suspected ACS.
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http://dx.doi.org/10.1186/1471-2261-11-57DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3199275PMC
September 2011

Low levels of the omega-3 index are associated with sudden cardiac arrest and remain stable in survivors in the subacute phase.

Lipids 2011 Feb 14;46(2):151-61. Epub 2011 Jan 14.

Department of Medicine, Stavanger University Hospital, PB 8100, 4068 Stavanger, Norway.

In previous studies, low blood levels of n-3 fatty acids (FA) have been associated with increased risk of cardiac death, and the omega-3 index (red blood cell (RBC) eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) expressed as weight percentage of total FA) has recently been proposed as a new risk factor for death from coronary artery disease, especially following sudden cardiac arrest (SCA). As blood samples often haven been harvested after the event, the aim of our study was to evaluate the stability of RBC fatty acids following SCA. The total FA profile, including the omega-3 index, was measured three times during the first 48 h in 25 survivors of out-of-hospital cardiac arrest (OHCA), in 15 patients with a myocardial infarction (MI) without SCA and in 5 healthy subjects. We could not demonstrate significant changes in the FA measurements in any of the groups, this also applied to the omega-6/omega-3 ratio and the arachidonic acid (AA)/EPA ratio. Furthermore, we compared the omega-3 index in 14 OHCA-patients suffering their first MI with that of 185 first-time MI-patients without SCA; mean values being 4.59% and 6.48%, respectively (p = 0.002). In a multivariate logistic regression analysis, a 1% increase of the omega-3 index was associated with a 58% (95% CI: 0.25-0.76%) reduction in risk of ventricular fibrillation (VF). In conclusion, the omega-3 index remained stable after an event of SCA and predicted the risk of VF.
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http://dx.doi.org/10.1007/s11745-010-3511-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3038230PMC
February 2011

Activated factor XII type A and B-type natriuretic peptide are complementary and incremental predictors of mortality in patients following admission with acute coronary syndrome.

Blood Coagul Fibrinolysis 2009 Dec;20(8):652-60

Institute of Medicine, University of Bergen, Bergen, Norway.

The aim of this analysis was to assess the predictive value of activated factor XII type A (XIIaA) and B-type natriuretic peptide (BNP) in acute coronary syndrome patients stratified according to troponin release and to evaluate their complementary utility as predictors of all-cause mortality and recurrent troponin T (TnT)-positive events. Multivariable analysis in 870 patients admitted with suspected myocardial infarction was performed using the Cox proportional hazard ratio model. Variables in the model included XIIaA and BNP as well as conventional risk factors for mortality. Although both XIIaA and BNP were identified as independent predictors for all-cause mortality in the total group of patients, only BNP was found to be an independent predictor for all-cause mortality in patients with a confirmed myocardial infarction (TnT > 0.05 ng/ml) at admission (hazard ratio 4.24, 95% confidence interval 1.28-14.07), whereas only XIIaA was an independent predictor for all-cause mortality in patients with low TnT release (0.01 < TnT < or = 0.05 ng/ml) at admission (hazard ratio 10.37, 95% confidence interval 2.89-37.21). The combination of these two biomarkers provided complementary prognostic information for all-cause mortality as compared with each of the biomarkers alone in the total patient material. XIIaA is particularly useful in predicting mortality in acute coronary syndrome patients with low troponin release, whereas BNP is effective in predicting mortality in patients with confirmed myocardial infarction and more substantial troponin release. The combination of these two biomarkers improves outcome prediction in unselected patients with chest pain and acute coronary syndrome.
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http://dx.doi.org/10.1097/MBC.0b013e32832fa814DOI Listing
December 2009
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