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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

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

Condition or disease
Acute Coronary Syndrome

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.


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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain (WESTCOR Study)
Study Start Date : September 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2036

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain




Primary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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

  2. Total mortality [ Time Frame: 5 years ]
    Patients will be followed for 1-5 years through national registers

  3. 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

  4. Cardiovascular mortality [ Time Frame: 5 years ]
    Patients will be followed for 1-5 years through national registers

  5. 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
Full blood, Serum samples, EDTA plasma, Urine


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

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


Contacts
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Contact: Kristin M Aakre, MD, PhD +4755973188 kristin.moberg.aakre@helse-bergen.no
Contact: Kjell Vikenes, MD, PhD +4755972172 kjell.vikenes@helse-bergen.no

Locations
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Norway
Haukeland University Hospital Recruiting
Bergen, Norway, 5020
Contact: Kristin M Aakre, MD, PhD    +4755973188    kristin.moberg.aakre@helse-bergen.no   
Contact: Kjell Vikenes, MD, PhD    +4755972172    kjell.vikenes@helse-bergen.no   
Stavanger University Hospital Not yet recruiting
Stavanger, Norway, 4011
Contact: Øyvind Skadberg, MD    +4751519545    oyvind.skadberg@sus.no   
Contact: Vernon VS Bonarjee, MD, PhD    +4751518824    vernon.vijay.singha.bonarjee@sus.no   
Sponsors and Collaborators
Haukeland University Hospital
Helse Stavanger HF
The Royal Norwegian Ministry of Health
Investigators
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Principal Investigator: Kristin M Aakre, MD, PhD Laboratory of Clinical Biochemistry, Haukeland University Hospital

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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT02620202     History of Changes
Other Study ID Numbers: 2014/1365
First Posted: December 2, 2015    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Keywords provided by Haukeland University Hospital:
Troponin
Myocardial infarction
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Chest Pain
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pain
Neurologic Manifestations
Signs and Symptoms