|- candidate number||2839|
|- NTR Number||NTR1106|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-okt-2007|
|- Secondary IDs||MEC-2007-184 MEC Erasmus MC Rotterdam|
|- Public Title||“BIOMarker PILOT study to identify the Acute risk of a Coronary Syndrome (BIOMArCS PILOT)” and “Hartinfarct-biomarker onderzoek (deel I)” . |
|- Scientific Title||Study of the evolution of biomarker patterns following admission for an acute coronary syndrome; BIOMarker study to identify the Acute risk of a Coronary Syndrome.
|- ACRONYM||BIOMArCS PILOT|
|- hypothesis||1. Vascular inflammation becomes activated several days to weeks before an acute coronary syndrome;|
2. Biomarkers of (vascular) inflammation, endothelial activation and hypercoagulability become elevated before the event. Limited knowledge is available about the evolution of biomarker patterns following an acute coronary syndrome;
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.
|- Healt Condition(s) or Problem(s) studied||Unstable angina pectoris, Acute coronary syndrome (ACS)|
|- Inclusion criteria||Patients to be included must meet the following criteria:|
1. Men or women with a minimum age of 40 years who are admitted with the clinical diagnosis of an acute coronary syndrome. The diagnosis should be based on the combination of typical ischemic chest complaints and objective evidence of myocardial ischemia or myocardial necrosis as demonstrated by the electrocardiogram (ECG) or elevated cardiac markers, as follows:
a. Typical ischemic chest pain, lasting 10 minutes or more, within the preceding 24 hours;
b. ECG changes indicative of myocardial ischemia within 24 hours after the onset of chest pain (ECG showing persistent or 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)
c. Elevated biomarkers of myocardial necrosis within 24 hours after the onset of chest pain (i.e. CK-MB >1 times the upper limit of normal of the local laboratory, or Troponin-T >0.05 ng/ml or Troponin-I > 0.05 ng/ml).
2. At least two of the following high-risk features: minimal age 65 (70) years in men (women), diabetes mellitus, hypertension, hypercholesterolemia, current smoking, prior angina, prior myocardial infarction, prior cerebrovascular disease, peripheral arterial disease, or microalbuminuria (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).
3. All patients have to provide written informed consent. Informed consent will be asked either by the treating physician or by a research-nurse.
|- Exclusion criteria||Patients will be excluded from this study for any of the following reasons:|
1. Myocardial ischemia precipitated by a condition other than atherosclerotic coronary artery disease (e.g. arrhythmia, severe anemia, hypoxia, thyrotoxicosis, cocaine, severe valvular disease, hypotension).
2. Severely-impaired left ventricular function (ejection fraction <30%) or end-stage congestive heart failure NYHA-class III or IV (in order to avoid lost-to-follow-up due to non-acute coronary syndrome events).
3. Severe chronic kidney disease with measured or calculated glomerular filtration rate (Cockgroft-Gault or MDRD4 (Modification of Diet in Renal Disease) formula) of <30 ml/min/1.73m2, or renal dialysis.
4. Co-existent condition associated with a life-expectancy <1 year, or otherwise unlikely to appear at all scheduled follow-up visits.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-jan-2008|
|- planned closingdate||1-jan-2011|
|- Target number of participants||100|
|- Interventions||None, this is an observational study.|
|- Primary outcome||The general aim of this trial is to identify appropriate biochemical markers that are associated with plaque instability and the development of acute coronary syndromes and to furthermore prospectively study and describe the variability and evolution of biomarker patterns in 100 patients during the first months after admission for an acute coronary syndrome.|
|- Secondary outcome||A subsequent aim of this trial is to create an infrastructure for repeated biomarker sampling that can easily be expanded to perform further projects involving biomarkers in acute coronary syndromes.|
|- Timepoints||Patient examination and venapunction for biomarker analysis at several predefined moments during both hospital admission for an acute coronary syndrome as well as during subsequent out-patient followup visits during several months following the acute coronary syndrome.|
|- 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)
|Interuniversity Institute of Cardiology (ICIN), The Netherlands, Royal Netherlands Academy of Arts and Sciences |
|- Brief summary||Coronary artery disease is a chronic progressive disease with multiple constituents involving amongst others lipid metabolism, inflammation, endothelial activation and thrombosis, and is predicted to become the dominant cause of mortality worldwide by 2020. Certain biochemical markers are believed to be indicative of the above-mentioned constituents and have been associated with an increased risk for the future development of acute coronary syndromes. However, limited knowledge is available about the evolution of biomarker patterns following an acute coronary syndrome. |
The general aim of this study is to identify appropriate biomarkers that are associated with the constituents and the development of acute coronary syndromes and to furthermore study and describe the variability and evolution patterns of these selected biomarkers in 100 patients during the first months after admission for an acute coronary syndrome.
A subsequent aim of this trial is to create an infrastructure for repeated biomarker sampling that can easily be expanded to perform further projects involving biomarkers in acute coronary syndromes, in order to eventually evaluate the use of biomarkers as a non-invasive, cost effective and accessible method of individual risk stratification in the dynamic processes of vascular inflammation, endothelial activation, atherogenesis, atherothrombosis and the development of acute coronary syndromes.
|- Main changes (audit trail)|
|- RECORD||29-okt-2007 - 1-apr-2009|