REPAIR-AMI: Intracoronary Progenitor Cells in Acute Myocardial Infarction (AMI)
This study has been completed.
Sponsor:
A. M. Zeiher
Collaborators:
Johann Wolfgang Goethe University Hospitals
Blutspendedienst Baden-Württemberg - Hessen
Guidant Corporation
Eli Lilly and Company
Information provided by (Responsible Party):
A. M. Zeiher, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00279175
First received: January 18, 2006
Last updated: September 19, 2012
Last verified: September 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 |
|---|---|---|
|
Myocardial Infarction |
Biological: Intracoronary infusion of enriched bone marrow-derived progenitor cells Biological: Placebo medium supplemented with autologous serum |
Phase 3 |
| 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 Myocardial Infarction (REPAIR - AMI) |
Resource links provided by NLM:
Further study details as provided by Johann Wolfgang Goethe University Hospitals:
Primary Outcome Measures:
- Change in global left ventricular function in quantitative LV angiography after 4 months. [ Time Frame: baseline to 4 months ] [ Designated as safety issue: No ]absolute delta LVEF (%)
Secondary Outcome Measures:
- Primary endpoint in patients without restenosis. [ Time Frame: baseline to 4 months ] [ Designated as safety issue: Yes ]absolute delta LVEF (%)
- Improvement of regional wall motion in infarct area [ Time Frame: baseline to 4 months ] [ Designated as safety issue: No ]
- Reduction of LV end-systolic volume [ Time Frame: baseline to 4 months ] [ Designated as safety issue: No ]
- Major adverse cardiac events (MACE) [ Time Frame: at 4, 12 and 60 months ] [ Designated as safety issue: Yes ]
- Rehospitalization due to heart failure. [ Time Frame: 4, 12, 60 months ] [ Designated as safety issue: Yes ]
- NYHA status after 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Amendment for extended follow up after 2 and 5 years: [ Time Frame: 24 and 60 months ] [ Designated as safety issue: Yes ]
- outcomes in major adverse cardiac events (MACE) [ Time Frame: 4, 12, 60 months ] [ Designated as safety issue: Yes ]
- Rehospitalization due to heart failure [ Time Frame: 4, 12, 60 months ] [ Designated as safety issue: Yes ]
- NYHA status [ Time Frame: 4, 12, 60 months ] [ Designated as safety issue: No ]
- patients in MRI subgroup: improvement in left ventricular function [ Time Frame: 4, 12, 60 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 204 |
| Study Start Date: | April 2004 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BMC
Intracoronary infusion of autologous bone marrow derived cells
|
Biological: Intracoronary infusion of enriched bone marrow-derived progenitor cells |
|
Placebo Comparator: Placebo
Intracoronary infusion of Placebo medium
|
Biological: Placebo medium supplemented with autologous serum |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00279175
Locations
| Germany | |
| Zentralklinik Bad Berka | |
| Bad Berka, Germany, 99437 | |
| Kerckhoff Klinik | |
| Bad Nauheim, Germany, 61231 | |
| Herz- und Diabeteszentrum NRW | |
| Bad Oeynhausen, Germany, 32545 | |
| BG Kliniken Bergmannsheil | |
| Bochum, Germany, 44789 | |
| Klinikum Lippe | |
| Detmold, Germany, 32756 | |
| J. W. Goethe University Hospitals | |
| Frankfurt, Germany, 60590 | |
| Rotes-Kreuz Krankenhaus - Kardiologisches Centrum | |
| Frankfurt, Germany, 60316 | |
| Universitätsklinkum Giessen | |
| Giessen, Germany, 35392 | |
| Parxis Schofer, Mathey und Partner | |
| Hamburg, Germany, 22763 | |
| Universitätsklikum Homburg | |
| Homburg/Saar, Germany, 66421 | |
| Klinikum Kassel | |
| Kassel, Germany, 34125 | |
| Herzzentrum - Universität Leipzig | |
| Leipzig, Germany, 04289 | |
| Herzzentrum Ludwigshafen | |
| Ludwigshafen, Germany, 67073 | |
| Universitätsklinik Mainz | |
| Mainz, Germany, 55131 | |
| Universitätsklinikum Mannheim | |
| Mannheim, Germany, 68167 | |
| Zentralklinikum Suhl | |
| Suhl, Germany, 98527 | |
| Switzerland | |
| Universitätsspital Zürich | |
| Zürich, Switzerland, 8091 | |
Sponsors and Collaborators
A. M. Zeiher
Johann Wolfgang Goethe University Hospitals
Blutspendedienst Baden-Württemberg - Hessen
Guidant Corporation
Eli Lilly and Company
Investigators
| Principal Investigator: | Andreas M Zeiher, MD | J. W. Goethe University Hospitals |
| Study Director: | Volker Schächinger, MD | J. W. Goethe University Hopspitals |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | A. M. Zeiher, Professor Dr. med., Johann Wolfgang Goethe University Hospitals |
| ClinicalTrials.gov Identifier: | NCT00279175 History of Changes |
| Other Study ID Numbers: | 2/04, Paul-Ehrlich-Institute 1034/01, EudraCT 2006-000250-43 |
| Study First Received: | January 18, 2006 |
| Last Updated: | September 19, 2012 |
| Health Authority: | Germany: Paul-Ehrlich-Institut |
Keywords provided by Johann Wolfgang Goethe University Hospitals:
|
Acute myocardial infarction |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013