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Sponsors and Collaborators: |
Johann Wolfgang Goethe University Hospitals Blutspendedienst Baden-Württemberg - Hessen Guidant Corporation Eli Lilly and Company |
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Information provided by: | Johann Wolfgang Goethe University Hospitals |
ClinicalTrials.gov Identifier: | NCT00279175 |
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.
Condition | Intervention | Phase |
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Myocardial Infarction |
Drug: Intracoronary infusion of enriched bone marrow-derived progenitor cells |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Reinfusion of Enriched Progenitor Cells And Infarct Remodeling in Acute Myocardial Infarction (REPAIR - AMI) |
Estimated Enrollment: | 200 |
Study Start Date: | April 2004 |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
Exclusion Criteria:
Germany | |
J. W. Goethe University Hospitals | |
Frankfurt, Germany, 60590 | |
Kerckhoff Klinik | |
Bad Nauheim, Germany, 61231 | |
Rotes-Kreuz Krankenhaus - Kardiologisches Centrum | |
Frankfurt, Germany, 60316 | |
Universitätsklinik Mainz | |
Mainz, Germany, 55131 | |
Universitätsklikum Homburg | |
Homburg/Saar, Germany, 66421 | |
Universitätsklinikum Mannheim | |
Mannheim, Germany, 68167 | |
BG Kliniken Bergmannsheil | |
Bochum, Germany, 44789 | |
Herzzentrum Ludwigshafen | |
Ludwigshafen, Germany, 67073 | |
Parxis Schofer, Mathey und Partner | |
Hamburg, Germany, 22763 | |
Herzzentrum - Universität Leipzig | |
Leipzig, Germany, 04289 | |
Zentralklinikum Suhl | |
Suhl, Germany, 98527 | |
Universitätsklinkum Giessen | |
Giessen, Germany, 35392 | |
Herz- und Diabeteszentrum NRW | |
Bad Oeynhausen, Germany, 32545 | |
Zentralklinik Bad Berka | |
Bad Berka, Germany, 99437 | |
Klinikum Lippe | |
Detmold, Germany, 32756 | |
Klinikum Kassel | |
Kassel, Germany, 34125 | |
Switzerland | |
Universitätsspital Zürich | |
Zürich, Switzerland, 8091 |
Principal Investigator: | Andreas M Zeiher, MD | J. W. Goethe University Hospitals |
Study Director: | Volker Schächinger, MD | J. W. Goethe University Hopspitals |
Study ID Numbers: | 2/04, Paul-Ehrlich-Institute 1034/01, EudraCT 2006-000250-43 |
Study First Received: | January 18, 2006 |
Last Updated: | November 21, 2006 |
ClinicalTrials.gov Identifier: | NCT00279175 History of Changes |
Health Authority: | Germany: Paul-Ehrlich-Institut |
Acute myocardial infarction |
Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases |
Ischemia Infarction Myocardial Infarction |
Necrosis Heart Diseases Pathologic Processes Myocardial Ischemia Vascular Diseases |
Cardiovascular Diseases Ischemia Infarction Myocardial Infarction |