|- candidate number||5418|
|- NTR Number||NTR1698|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-mrt-2009|
|- Secondary IDs||2007-185/07101/2007B012 MEC/ICIN/NHS |
|- Public Title||"BIOMarker study to identify the Acute risk of a Coronary Syndrome (BIOMArCS)" and "Hartinfarct-biomarker studie (deel II)". |
|- Scientific Title||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.|
|- hypothesis||1. Vascular inflammation becomes activated several days to weeks before an acute coronary syndrome;|
2. Biomarkers of vascular inflammation, distorted lipid metabolism, endothelial dysfunction, diminished endothelial regenerative capacity, hypercoagulability and myocardial ischemia become elevated before the event;
3. Hence, serial biomarker measurements might be used to identify vulnerable periods in the life-time of patients with established cardiovascular disease (as well as in individuals with prevalent but yet unrecognised cardiovascular disease), during which they are at increased risk of developing an acute coronary syndrome;
4. An imminent acute coronary syndrome might be prevented by future intensified medical treatment, or by a percutaneous coronary intervention.
|- Healt Condition(s) or Problem(s) studied||Acute coronary syndrome (ACS)|
|- 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;
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||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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-jan-2008|
|- planned closingdate||1-jun-2011|
|- Target number of participants||700|
|- Interventions||None, strictly observational post-ACS study.|
|- Primary outcome||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. |
|- Secondary outcome||N/A|
|- Timepoints||Total follow-up duration is 1 year. Patient interviews and blood sample collection and are planned during hospital admission for and acute coronary syndrome and subsequently every two week during the first half year of follow-up and monthly during the last half year of follow-up.|
|- Trial web site||www.biomarcs.org|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD R.M. Oemrawsingh|
|- CONTACT for SCIENTIFIC QUERIES||MD R.M. Oemrawsingh|
|- Sponsor/Initiator ||Prof. Eric Boersma, MSc, PhD, FESC, Professor of clinical epidemiology of cardiovascular diseases |
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center, Rotterdam, Dutch Heart Foundation (Nederlandse Hartstichting), Interuniversity Institute of Cardiology (ICIN), The Netherlands|
|- Brief summary||BIOMArCS is a multi-centre, prospective, observational study with 1-year follow-up of 700 patients after ACS, either with or without ST-elevation. Patients with at least two cardiovascular risk factors are included, so that the primary endpoint (cardiovascular mortality or repeat non-fatal ACS) is likely to occur in 10% of the cohort. Venapuncture is planned every fortnight during the first half-year and monthly thereafter. Biomarker patterns prior to the endpoint will be determined at the end of follow-up in the (suspected) 70 cases and compared to 210 event-free, matching controls.
|- Main changes (audit trail)|
|- RECORD||10-mrt-2009 - 14-sep-2009|