Effects of Intracoronary Progenitor Cell Therapy on Coronary Flow Reserve After Acute MI (REPAIR-ACS)
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Purpose
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 |
|---|---|---|
|
Coronary Artery Disease Acute Myocardial Infarction |
Biological: autologous bone marrow-derived progenitor cells Biological: placebo medium |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Reinfusion of Enriched Progenitor Cells And Infarct Remodeling in Acute Coronary Syndrome: REPAIR - ACS |
- Improvement of coronary flow reserve in the infarct vessel [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Improvement of relative coronary flow reserve [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Improvement of global and regional left ventricular ejection fraction [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Major adverse cardiac events (death, MI, rehospitalization for heart failure, revascularization) [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
- Major adverse cardiac events (death, MI, rehospitalization for heart failure, revascularization) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Intracoronary infusion of autologous bone marrow-derived progenitor cells after NSTEMI
|
Biological: autologous bone marrow-derived progenitor cells
intracoronary infusion of autologous bone marrow-derived progenitor cells isolated from 50 ml bone marrow aspirate
|
|
Placebo Comparator: 2
Intracoronary infusion of Placebo after NSTEMI
|
Biological: placebo medium
intracoronary infusion of placebo medium
|
Detailed Description:
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.
Eligibility| 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:
- Acute percutaneous revascularization with stent implantation within 48 hours after symptom onset.
- Successful acute PCI (residual stenosis < 30%, TIMI flow > 2).
- Hemodynamic stability
- Age 18 - 80 years
- Written informed consent
- Active contraception in women of childbearing age
Exclusion Criteria:
- Patients with STEMI (ST elevation in 2 leads above 0,2 mV in lead V1, V2 oder V3 or above 0,1 mV in the other leads)
- Necessity of additional PCI in non-infarct vessel at the time of study therapy (multi-vessel PCI in the acute event is possible)
- Heart failure (LVEF ≤ 30 %).
- Arteriovenous malformation or aneurysms
- Active infection (C-reactive protein > 10 mg/dl), or fever, or diarrhoea within the last 4 weeks
- Chronic inflammatory disease
- HIV infection or active hepatitis
- Neoplastic disease without documented complete remission within the last 5 years
- Recent stroke within the last 3 months
- Impaired kidney function (creatinin > 2,5 mg/dl) at the time of treatment
- Significant liver disease (GOT > 2x upper normal value or spontaneous INR > 1,5.
- Hematopoetic disease (anaemia with Hb< 8.5 mg/dl; thrombocytopenia < 100.000/µl; splenomegaly
- Known allergies to Clopidogrel, Heparin or Abciximab
- History of bleeding disorder
- GI bleeding within the last 3 months
- Major surgery or trauma within the last 2 months
- Uncontrolled hypertension
- Pregnancy
- Mental disability
- Previous progenitor cell therapy
- Participation in a different clinical trial within the last 30 days
Contacts and Locations| 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 | Goethe University |
More Information
Additional Information:
Publications:
| Responsible Party: | A. M. Zeiher, Prof. Dr. Andreas M. Zeiher, Johann Wolfgang Goethe University Hospitals |
| ClinicalTrials.gov Identifier: | NCT00711542 History of Changes |
| Other Study ID Numbers: | 2007-08-16 REPAIR-ACS |
| Study First Received: | July 8, 2008 |
| Last Updated: | September 19, 2012 |
| Health Authority: | Germany: Paul-Ehrlich-Institut |
Keywords provided by Johann Wolfgang Goethe University Hospitals:
|
intracoronary progenitor cell therapy NSTEMI coronary flow reserve randomized doubleblind Placebo-controlled trial |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Infarction Myocardial Infarction Acute Coronary Syndrome Heart Diseases Cardiovascular Diseases Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Ischemia Pathologic Processes Necrosis Angina Pectoris Chest Pain Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013