REPAIR-AMI: Intracoronary Progenitor Cells in Acute Myocardial Infarction (AMI)
- Conditions
- Myocardial Infarction
- Interventions
- Biological: Intracoronary infusion of enriched bone marrow-derived progenitor cellsBiological: Placebo medium supplemented with autologous serum
- Registration Number
- NCT00279175
- Lead Sponsor
- A. M. Zeiher
- Brief Summary
Impaired contractile function after a heart attack of the heart is a major cause of "heart failure" limiting quality of life and prognosis, which cannot be prevented even with optimal standard therapy, including immediate balloon/stent dilation of the infarct vessel.
The aim of the REPAIR-AMI trial is to investigate whether infusion of progenitor cells into the infarct vessel (after successful reperfusion therapy) may improve left ventricular contractile function compared to placebo therapy. After bone marrow aspiration progenitor cells are enriched via a centrifugation method.
- Detailed Description
* The study is a double-blind, placebo-controlled, randomized, multicenter trial.
* Patients after an acute myocardial infarction, undergoing successful reperfusion therapy are included.
* All patients undergo bone marrow aspiration 3 to 6 days after the infarction.
* After cell processing, enriched bone marrow-derived progenitor cells or placebo medium is infused direct into the infarct related artery during stop-flow. In addition, a left ventricular angiography is performed.
* After 4 months left ventricular angiography is repeated. The primary endpoint is the difference in change of left ventricular ejection fraction between the two groups.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 204
-
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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BMC Intracoronary infusion of enriched bone marrow-derived progenitor cells Intracoronary infusion of autologous bone marrow derived cells Placebo Placebo medium supplemented with autologous serum Intracoronary infusion of Placebo medium
- Primary Outcome Measures
Name Time Method Change in global left ventricular function in quantitative LV angiography after 4 months. baseline to 4 months absolute delta LVEF (%)
- Secondary Outcome Measures
Name Time Method NYHA status after 12 months 12 months Rehospitalization due to heart failure. 4, 12, 60 months Primary endpoint in patients without restenosis. baseline to 4 months absolute delta LVEF (%)
Improvement of regional wall motion in infarct area baseline to 4 months Reduction of LV end-systolic volume baseline to 4 months Major adverse cardiac events (MACE) at 4, 12 and 60 months Amendment for extended follow up after 2 and 5 years: 24 and 60 months outcomes in major adverse cardiac events (MACE) 4, 12, 60 months Rehospitalization due to heart failure 4, 12, 60 months NYHA status 4, 12, 60 months patients in MRI subgroup: improvement in left ventricular function 4, 12, 60 months
Trial Locations
- Locations (17)
Herz- und Diabeteszentrum NRW
🇩🇪Bad Oeynhausen, Germany
BG Kliniken Bergmannsheil
🇩🇪Bochum, Germany
Kerckhoff Klinik
🇩🇪Bad Nauheim, Germany
Klinikum Kassel
🇩🇪Kassel, Germany
Universitätsklinkum Giessen
🇩🇪Giessen, Germany
Herzzentrum - Universität Leipzig
🇩🇪Leipzig, Germany
Zentralklinikum Suhl
🇩🇪Suhl, Germany
Parxis Schofer, Mathey und Partner
🇩🇪Hamburg, Germany
Klinikum Lippe
🇩🇪Detmold, Germany
Herzzentrum Ludwigshafen
🇩🇪Ludwigshafen, Germany
Universitätsklikum Homburg
🇩🇪Homburg/Saar, Germany
Universitätsklinik Mainz
🇩🇪Mainz, Germany
Universitätsklinikum Mannheim
🇩🇪Mannheim, Germany
Zentralklinik Bad Berka
🇩🇪Bad Berka, Germany
Rotes-Kreuz Krankenhaus - Kardiologisches Centrum
🇩🇪Frankfurt, Germany
J. W. Goethe University Hospitals
🇩🇪Frankfurt, Germany
Universitätsspital Zürich
🇨🇭Zürich, Switzerland