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"BIOMarker study to identify the Acute risk of a Coronary Syndrome (BIOMArCS)" and "Hartinfarct-biomarker studie (deel II)".

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.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON27734
Enrollment
700
Registered
2009-03-06
Start date
2008-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome (Unstable Angina, Non ST-Elevatiom Myocardial infarction and ST-elevation Myocardial Infarction)

Interventions

None, strictly observational post-ACS study.

Sponsors

Principal investigator: Prof. Eric Boersma, PhD, MSc, FESC. Department of Cardiology, unit Clinical Epidemiology, ErasmusMC Rotterdam, The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Complaints of typical ischemic chest pain, lasting 10 minutes or more within the preceding 24 hours prior to presentation; 2a. ECG: (Non-)persistent ST segment elevation > 1.0 mm in two or more contiguous leads or dynamic ST segment depression > 1.0 mm in two or more contiguous leads; OR 2b. CK-MB or Troponin I > the upper normal limit or Troponin T > 0.05 µg/L (ng/ml); 3. Age ≥ 40 years; 4. Presence of ≥ 2 conventional risk factors (Age ≥ 65 years in males, age ≥ 70 years in females, diabetes mellitus, hypertension, hypercholesterolemia, current smoking, prior angina, prior myocardial infarction, prior cerebrovascular disease, peripheral arterial disease or microalbuminuria*, positive family history of coronary artery disease §); 5. Written informed consent. * Defined as >2.5-25 mg albumin/mmol creatinin for men and >3.5-35 mg for women, or >20-200 mg/l urinary albumin concentration in a single urine sample. § Angina pectoris, myocardial infarction, or sudden abrupt death without obvious cause, before the age of 55 in a first-degree blood relative.

Exclusion criteria

Exclusion criteria: 1. Myocardial ischemia precipitated by a condition other than atherosclerotic coronary artery disease (e.g. arrhythmia, severe anemia, hypoxia, thyrotoxicosis, cocaine abuse, severe valvular disease, hypotension); 2. Left ventricular ejection fraction < 30 % or end-stage congestive heart failure (NYHA class III or IV); 3. Renal dialysis or severe chronic kidney disease with measured or calculated GFR (Cockroft-Gault or MDRD4 formula) of < 30 ml/min/1.73 m2; 4. Co-existent condition with life-expectancy < 1 year or otherwise not expected to complete follow-up.

Design outcomes

Primary

MeasureTime frame
The primary endpoint is a composite of cardiovascular mortality or a clinical diagnosis of a non-fatal acute coronary syndrome during 1-year follow-up.

Contacts

Public ContactR.M. Oemrawsingh
r.oemrawsingh@erasmusmc.nl+31 (0)10 7035048

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)