A multi-centre, double-blind, randomised, placebo-controlled trial using CD133 enriched bone marrow cells following primary angioplasty for acute myocardial infarction with central core laboratory analysis. - SELECT-AMI
- Conditions
- Patients with acute ST-elevated myocardial infarction treated with primary percutaneous coronary interventionMedDRA version: 9.1Level: LLTClassification code 10000891Term: Acute myocardial infarction
- Registration Number
- EUCTR2007-001448-33-BE
- Lead Sponsor
- Cardiovascular Centre Aalst
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 60
1. Primary coronary intervention (PCI) for acute ST elevated myocardial infarction between 2-24 hours after onset of chest pain.
2. ST-segment elevation >= 2mm in >= 3 adjacent leads.
3. Presence of severe hypokinesia and/or akinesia in >=2 adjacent segments on echocardiogram at 48-72 hours after primary PCI.
4. Age between 20 and 70 years.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Pregnant or lactating.
2. Prior history of myocardial infarction before the index event.
3. Decompensated congestive heart failure.
4. Pre-exisiting LV dysfunction.
5. Cardiomyopathy.
6. Previous cardiac surgery.
7. Congenital heart disorder.
8. Paroxysmal atrial fibrillation or history of verntricular arrhythmias.
10. Presence of pacemaker or defibrillator.
12. contraindication to bone marrow aspiration.
15. 3-vessel coronary artery disease necessitating intervention within 4 months.
16. Immune compromise including HIV, HBV, HCV infection.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method