Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain

Acute Coronary Syndrome Clinical Trial

— WESTCOR  

Official title:

Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain (WESTCOR Study)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02620202
• Other study ID #: 2014/1365
• Status: Terminated
• Start date: September 2015
• Est. completion date: May 2020

Study information

• Verified date: July 2020
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1900
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Chest Pain

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
Norway	Stavanger University Hospital	Stavanger

Sponsors (3)

Lead Sponsor	Collaborator
Haukeland University Hospital	Helse Stavanger HF, The Royal Norwegian Ministry of Health

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients with chest pain that are diagnosed with NSTEMI based on troponin concentration	Stratified according to gender, age and co-morbidities	1-3 hours
Other	Total mortality	Patients will be followed for 1-5 years through national registers	5 years
Other	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)	Patients will be followed for 1-5 years through national registers	5 years
Other	Cardiovascular mortality	Patients will be followed for 1-5 years through national registers	5 years
Other	The incidence of major coronary events defined as (composite endpoint including MI, UAP, stable angina (requiring hospitalization), revascularization)	Patients will be followed for 1-5 years through national registers	5 years
Primary	Number of patients with chest pain that are diagnosed with acute coronary syndrome based on troponin concentrations	Stratified according to gender, age and co-morbidities	1-3 hours