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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 : Recruiting
First Posted : December 2, 2015
Last Update Posted : December 7, 2018
Sponsor:
Collaborators:
Helse Stavanger HF
The Royal Norwegian Ministry of Health
Information provided by (Responsible Party):
Haukeland University Hospital

Tracking Information
First Submitted Date October 12, 2015
First Posted Date December 2, 2015
Last Update Posted Date December 7, 2018
Study Start Date September 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 5, 2018)
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
Original Primary Outcome Measures
 (submitted: November 30, 2015)
Number of patients with chest pain that are diagnosed with acute coronary syndrom based on hs-cTn results [ Time Frame: 1-3 hours ]
Stratified according to gender, age and co-morbidities
Change History Complete list of historical versions of study NCT02620202 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: December 5, 2018)
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: November 30, 2015)
  • Quantify the number of hs-cTn assay results from a chest pain population that are affected by analytical interference [ Time Frame: 3 months ]
    Compare number of samples with analytical interferenc for hs-cTnT vs hs-cTnI (Abbott)
  • Measure the ability hs-cTn quantification may have to predicting cardiovascular events and all cause mortality in patients who have been hospitalized due to chest pain [ Time Frame: 20 years ]
    Patients will be followed for up to 20 years through national registers
 
Descriptive Information
Brief Title Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain
Official Title Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain (WESTCOR Study)
Brief Summary

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
Detailed Description

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 750 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.

2250 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
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Full blood, Serum samples, EDTA plasma, Urine
Sampling Method Probability Sample
Study Population Patients admitted to the Emergency Department at Haukeland University Hospital or Stavanger University Hospital with symptoms indicative of acute coronary syndrome
Condition Acute Coronary Syndrome
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 30, 2015)
3000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2036
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients admitted to the Emergency Department with a clinical suspicion of acute coronary syndrome i.e. chest pain or pain radiating down the arms, the back, into the jaw, throat or into the lower teeth. Chest pain must not be the most dominant symptom but may or may not be combined with e.g. dyspnea, nausea, anxiousness or palpitations.
  • Age >= 18 years

Exclusion Criteria:

  • ST elevation MI
  • Age < 18 years
  • Patients not able to give informed consent
  • Patients suffering from terminal illness (life expectance < 1 month)
  • Patients already included in the study
  • Patients who have been stabilized at local hospitals and are referred for second opinion e.g. coronary angiography
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Kristin M Aakre, MD, PhD +4755973188 kristin.moberg.aakre@helse-bergen.no
Contact: Kjell Vikenes, MD, PhD +4755972172 kjell.vikenes@helse-bergen.no
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT02620202
Other Study ID Numbers 2014/1365
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Haukeland University Hospital
Study Sponsor Haukeland University Hospital
Collaborators
  • Helse Stavanger HF
  • The Royal Norwegian Ministry of Health
Investigators
Principal Investigator: Kristin M Aakre, MD, PhD Laboratory of Clinical Biochemistry, Haukeland University Hospital
PRS Account Haukeland University Hospital
Verification Date December 2018