Patients with acute ST-elevated myocardial infarction treated with primary percutaneous coronary intervention MedDRA version: 9.1 Level: LLT Classification code 10000891 Term: Acute myocardial infarction
Conditions
Interventions
Trade Name: Enriched (using CliniMACS(r) Reagent System) CD133+, bone marrow derived, autologous progenitor cells
Product Name: CD133+ bone-marrow derived, autologous progenitor cells.
Product Code: C
Sponsors
Cardiovascular Centre Aalst
King’s College London
Catharina Hospital Eindhoven
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). 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. Efficacy: Comparison of chanegs in myocardial thickening in non-viable akinetic / hypokinetic wall segments as determined by cardiac MRS in treated and control groups. | — |
Countries
Netherlands
Outcome results
None listed