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 intervention; MedDRA version: 9.1Level: LLTClassification code 10000891Term: Acute myocardial infarction

• Registration Number: EUCTR2007-001448-33-NL
• Lead Sponsor: Cardiovascular Centre Aalst

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-25
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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 Objective: See protocol page 6 and 7 and § 20, page 21-23.;Main Objective: 1. To determione the safety of intra-coronary infusion of enriched CD133+, bone-marrow-derived, autologous progenitor cells in patients 5-10 days after acute percuteneous coronary revascularization for ST-segment elevation myocardial infarction (STEMI).<br><br>2. To determine whether intra-coronary infusion of enriched CD133+, bone-marrow-derived, autologous progenitor cells i patients 5-10 days after percuteneous coronary revascularization for STEMI imporves left ventricular thickening in akinetic/hypokinetic segments.;Primary end point(s): Safety: Comparison of progression in coronary atheroscelosis burden proximal and distal to the stented segment of the infarct-related artery in treated and control groups.<br><br>Efficacy: Comparison of chanegs in myocardial thickening in non-viable akinetic / hypokinetic wall segments as determined by cardiac MRS in treated and control groups.