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Sponsors and Collaborators: |
Johann Wolfgang Goethe University Hospitals University of Leipzig |
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Information provided by: | Johann Wolfgang Goethe University Hospitals |
ClinicalTrials.gov Identifier: | NCT00711542 |
Coronary flow reserve is an important measure of the integrity of the coronary microcirculation. Moreover, impaired coronary flow reserve is a predictor of future cardiovascular events and poor prognosis in patients after acute myocardial infarction. After acute myocardial infarction, coronary flow reserve remains significantly reduced. A previous randomized, double-blind Placebo-controlled trial (REPAIR-AMI) demonstrated complete normalization of coronary flow reserve after intracoronary application of autologous bone marrow-derived progenitor cells (but no effect in the placebo group) in patients with ST segment elevation myocardial infarction. The current study is planned to extend these findings to patients with Non-ST segment elevation myocardial infarction, since these patients have an equally reduced outcome.
Condition | Intervention | Phase |
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Coronary Artery Disease Acute Myocardial Infarction |
Biological: autologous bone marrow-derived progenitor cells Biological: placebo medium |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Reinfusion of Enriched Progenitor Cells And Infarct Remodeling in Acute Coronary Syndrome: REPAIR - ACS |
Estimated Enrollment: | 100 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | April 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Intracoronary infusion of autologous bone marrow-derived progenitor cells after NSTEMI
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Biological: autologous bone marrow-derived progenitor cells
intracoronary infusion of autologous bone marrow-derived progenitor cells isolated from 50 ml bone marrow aspirate
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2: Placebo Comparator
Intracoronary infusion of Placebo after NSTEMI
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Biological: placebo medium
intracoronary infusion of placebo medium
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Improvement of neovascularization is a key mechanism of functional improvement of intracoronary application of progenitor cells after acute myocardial infarction. Since capillary density cannot be assessed histological in patients, measurement of coronary flow reserve is an exact means for estimating capillary density and assessing coronary microvascular function. With the help of an intracoronary Doppler Wire, coronary hemodynamics can be assessed at baseline and, for example, adenosin-induced maximal vasodilation. Calculation of the minimal vascular resistance indices allows to estimate the cross-sectional area, reflecting capillary density, and, in comparison with the time of the acute myocardial infarction, estimation of improved neovascularization at a later timepoint.
In order to improve neovascularization, which may then be associated with improved left ventricular contractility, we initiated the current trial.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with acute coronary syndrome (ST-depression in at least 2 leads > 0,1 mV), or T-wave inversion, with or without elevated myocardial biomarkers (Troponin T oder I), together with typical clinical presentation), treated as follows:
Exclusion Criteria:
Contact: Andreas M Zeiher, MD | +49 69 6301 ext 5789 | zeiher@em.uni-frankfurt.de |
Contact: Birgit Assmus, MD | +49 69 6301 ext 7387 | b.assmus@em.uni-frankfurt.de |
Germany | |
Med. Klinik III; Kardiologie | Recruiting |
Frankfurt, Germany, 60590 | |
Contact: Birgit Assmus, MD +49 69 6301 ext 7387 b.assmus@em.uni-frankfurt.de | |
Contact: Stefan Fichtlscherer, MD +49 69 6301 ext 7387 fichtlscherer@em.uni-frankfurt.de | |
Sub-Investigator: Birgit Assmus, MD | |
Principal Investigator: Andreas M Zeiher, MD | |
Universität Leipzig / Herzzentrum | Recruiting |
Leipzig, Germany, 04289 | |
Contact: Gerhard Schuler, MD +49 341 865 ext 1428 gerhard.schuler@medizin.uni-leipzig.de | |
Contact: Sandra Erbs +49 341 865 ext 1428 Sandra.Erbs@medizin.uni-leipzig.de | |
Principal Investigator: Gerhard Schuler, MD | |
Sub-Investigator: Sandra Erbs, MD |
Principal Investigator: | Andreas M Zeiher, MD | Johann Wolfgang Goethe University |
Responsible Party: | Johann Wolfgang Goethe University ( Prof. Dr. Andreas M Zeiher ) |
Study ID Numbers: | 2007-08-16 REPAIR-ACS |
Study First Received: | July 8, 2008 |
Last Updated: | August 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00711542 History of Changes |
Health Authority: | Germany: Paul-Ehrlich-Institut |
intracoronary progenitor cell therapy NSTEMI coronary flow reserve randomized doubleblind Placebo-controlled trial |
Arterial Occlusive Diseases Coronary Disease Necrosis Heart Diseases Myocardial Ischemia Acute Coronary Syndrome |
Vascular Diseases Arteriosclerosis Ischemia Infarction Myocardial Infarction Coronary Artery Disease |
Arterial Occlusive Diseases Heart Diseases Myocardial Ischemia Vascular Diseases Arteriosclerosis Ischemia Coronary Disease |
Necrosis Pathologic Processes Cardiovascular Diseases Infarction Myocardial Infarction Coronary Artery Disease |