Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain (WESTCOR)
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|ClinicalTrials.gov Identifier: NCT02620202|
Recruitment Status : Terminated (It was no longer possible to include patients due to logistic challanges occuring during the Covid-19 pandemic)
First Posted : December 2, 2015
Last Update Posted : April 28, 2021
The main aim of the WESTCOR study is to
- investigate the ability of two high sensitive cardiac troponin (hs-cTn) assays to diagnose acute coronary syndrome and predict prognosis in different patient populations (e.g. gender, age and co-morbidity)
- to validate the suggested 1 hour protocol for rule in and rule out of acute coronary syndrome for two hs-cTn assays in an unselected chest pain population
- to investigate different biomarkers ability to predict long term prognosis after hospitalization for chest pain
|Condition or disease|
|Acute Coronary Syndrome|
The WESTCOR-study will include patients presenting to the Emergency Department of Haukeland University Hospital and Stavanger University Hospital with symptoms indicative of acute coronary syndrome. 1500 patients will be included at Haukeland University Hospital and 400 at Stavanger University Hospital. The two locations use different high sensitive troponin assays (i.e. hs-cTnT and hs-cTnI (Abbott Diagnostics) for routine diagnostic of coronary syndrome.
1900 patients will be sampled and hs-cTnT or hs-cTnI (as applicable) will be measured at admission, after one (2/3 of the cohort), three hours and after 8-12 hours. Clinicians will be blinded to the results of the hs-cTn assay that is not used as routine assay locally. Final diagnosis will be made by two independent cardiologists based on all available clinical information and results of the routine tests. The ability to diagnose or exclude MI ACS, and MACE at different sampling points in different patient populations will be compared for different biomarkers. 1500 patients will have a sample 1 hour after admission. The clinicians will be blinded to the results of this sample (both hs-cTn assays). The ability of the one-hour sample to diagnose or exclude myocardial infraction (MI), ACS and MACE will be compared between biomarkers.
All patients will be invited to take a follow-up sample 3 months after discharge.
The patients will further be followed for 1-5 years through national registers and the prognostic value of hs-cTn concentrations and dynamics as well as other biomarkers, will be measured.
|Study Type :||Observational|
|Actual Enrollment :||1900 participants|
|Official Title:||Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain (WESTCOR Study)|
|Actual Study Start Date :||September 2015|
|Actual Primary Completion Date :||May 2020|
|Actual Study Completion Date :||May 2020|
- Number of patients with chest pain that are diagnosed with acute coronary syndrome based on troponin concentrations [ Time Frame: 1-3 hours ]Stratified according to gender, age and co-morbidities
- Number of patients with chest pain that are diagnosed with NSTEMI based on troponin concentration [ Time Frame: 1-3 hours ]Stratified according to gender, age and co-morbidities
- Total mortality [ Time Frame: 5 years ]Patients will be followed for 1-5 years through national registers
- The incidence of major cardiovascular events (MACE) defined as (composite endpoint including MI, UAP, stable angina (requiring hospitalization), revascularization, stroke, heart failure and cardiac arrhythmias) [ Time Frame: 5 years ]Patients will be followed for 1-5 years through national registers
- Cardiovascular mortality [ Time Frame: 5 years ]Patients will be followed for 1-5 years through national registers
- The incidence of major coronary events defined as (composite endpoint including MI, UAP, stable angina (requiring hospitalization), revascularization) [ Time Frame: 5 years ]Patients will be followed for 1-5 years through national registers
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02620202
|Haukeland University Hospital|
|Bergen, Norway, 5020|
|Stavanger University Hospital|
|Stavanger, Norway, 4011|
|Principal Investigator:||Kristin M Aakre, MD, PhD||Laboratory of Clinical Biochemistry, Haukeland University Hospital|