Study of the relation between biomarker patterns and the incidence of recurrent coronary events during 1-year follow-up in patients who were hospitalised for an acute coronary syndrome; BIOMarker Study to identify the Acute risk of a Coronary Syndrome (BIOMArCS)

Completed

• Conditions: coronary artery disease; 'furring' of the coronary arteries; 10011082; 10003216

• Registration Number: NL-OMON43706
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 900

Inclusion Criteria

- At least 40 years of age
-A high-risk profile with regard to the occurrence of primary endpoint during follow-up,
as indicated by the presence of at least 2 points. 2 Points are given in case of presence of one the following risk factors: Age * 75 years, diabetes mellitus, prior angina, prior myocardial infarction, prior cerebrovascular disease, peripheral arterial disease. 1 Point is given in case of presence of one the following risk factors: Age > 65 years in men and > 70 years in women, Hypertension, Hypercholesterolemia, Current smoking, Microalbuminuria

Exclusion Criteria

- Myocardial ischemia precipitated by a condition other than atherosclerotic coronary artery disease
- Severely-impaired left ventricular function or end-stage congestive heart failure NYHA-class III or IV
- Severe chronic kidney disease
- Co-existent condition associated with a life-expectancy <1 year, or otherwise unlikely to appear at all scheduled follow-up visits

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary determinants ('study parameters'): biomarkers of vascular inflammation,<br /><br>plaque instability and hypercoagulability<br /><br>The primary endpoint is a composite of cardiovascular mortality , non-fatal<br /><br>acute coronary syndrome or unplanned coronary revascularization due to<br /><br>progressive angina pectoris during 1-year follow-up.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are<br /><br>1. A composite of cardiovascular mortality and non-fatal acute coronary<br /><br>syndrome only;<br /><br>2. A composite of cardiovascular mortality, non-fatal acute coronary syndrome<br /><br>and all coronary revascularizations (including staged/planned procedures);<br /><br>3. A composite of cardiovascular mortality, non-fatal acute coronary syndrome,<br /><br>unplanned coronary revascularization, re-hospitalization for angina or stroke.</p><br>