REPAIR-AMI: Intracoronary Progenitor Cells in Acute Myocardial Infarction (AMI)
Myocardial Infarction
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring Acute myocardial infarction
Eligibility Criteria
Inclusion Criteria: Patients with acute myocardial infarction (ST elevation in at least 2 leads >= 0.2 mV in V1,V2 or V3 or >= 0.1 mV in other leads), treated by one of the following procedures Either acute PCI with stent implantation within 24 hours after symptom onset or treatment with thrombolysis within 12 hours of symptom onset followed by PCI with stent implantation within 24 hours after thrombolysis. Acute PCI / stent implantation has been successful (residual stenosis visually < 30% and TIMI flow >= 2). At the time of inclusion patient does no longer require i.v. catecholamines or mechanical hemodynamic support (aortic balloon pump) Significant regional wall motion abnormality in LV angiogram at the time of acute PCI (ejection fraction <= 45% on visual estimation). Maximal CK elevation >= 400 U/l (measured at 37° C) with significant MB fraction > 6% Age 18 - 80 Years Written informed consent Exclusion Criteria: Regional wall motion abnormality outside the area involved in the index acute myocardial infarction. Need to revascularize additional vessels, outside the infarct artery. Arteriovenous malformations or aneurysms Active infection (CRP > 10 mg/dl) now, or fever or diarrhea within last 4 weeks. Chronic inflammatory disease HIV infection or active hepatitis Neoplastic disease without documented remission within the past 5 years. Cerebrovascular insult within 3 months Impaired renal function (creatinine > 2 mg/dl) at the time of cell therapy Significant liver disease (GOT > 2x upper limit) or spontaneous INR > 1,5) Anemia (hemoglobin < 8.5 mg/dl) Platelet count < 100.000/µl Hypersplenism Known allergy or intolerance to clopidogrel, heparin or abciximab. History of bleeding disorder Gastrointestinal bleeding within 3 months Major surgical procedure or traumata within 2 months Uncontrolled hypertension Pregnancy Mental retardation Previously performed stem / progenitor cell therapy Participation in another clinical trial within the last 30 days.
Sites / Locations
- Zentralklinik Bad Berka
- Kerckhoff Klinik
- Herz- und Diabeteszentrum NRW
- BG Kliniken Bergmannsheil
- Klinikum Lippe
- Rotes-Kreuz Krankenhaus - Kardiologisches Centrum
- J. W. Goethe University Hospitals
- Universitätsklinkum Giessen
- Parxis Schofer, Mathey und Partner
- Universitätsklikum Homburg
- Klinikum Kassel
- Herzzentrum - Universität Leipzig
- Herzzentrum Ludwigshafen
- Universitätsklinik Mainz
- Universitätsklinikum Mannheim
- Zentralklinikum Suhl
- Universitätsspital Zürich
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
BMC
Placebo
Intracoronary infusion of autologous bone marrow derived cells
Intracoronary infusion of Placebo medium