1. Acute coronary syndromes
Conditions
Interventions
Sponsors
Initiator / Lead Principal Investigator:
H. Boersma, PhD, MSc.
Erasmus Medical Center (EMC), Department of Cardiology, section Clinical Epidemiology.
Postaddress: P.O. Box 2040, 3000 CA Rotterdam
Address: 's-Gravendijkwal 230
Postalcode: 3015 CE
City: Rotterdam
Country: Netherlands
Telephone: +31 10 4632307
Fax: +31 10 4089484
E-mail: h.boersma@erasmusmc.nl
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactR.M. Oemrawsingh
Outcome results
None listed