REPAIR-AMI: Intracoronary Progenitor Cells in Acute Myocardial Infarction (AMI)

September 19, 2012 updated by: A. M. Zeiher

Reinfusion of Enriched Progenitor Cells And Infarct Remodeling in Acute Myocardial Infarction (REPAIR - AMI)

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

204

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bad Berka, Germany, 99437
        • Zentralklinik Bad Berka
      • Bad Nauheim, Germany, 61231
        • Kerckhoff Klinik
      • Bad Oeynhausen, Germany, 32545
        • Herz- und Diabeteszentrum NRW
      • Bochum, Germany, 44789
        • BG Kliniken Bergmannsheil
      • Detmold, Germany, 32756
        • Klinikum Lippe
      • Frankfurt, Germany, 60590
        • J. W. Goethe University Hospitals
      • Frankfurt, Germany, 60316
        • Rotes-Kreuz Krankenhaus - Kardiologisches Centrum
      • Giessen, Germany, 35392
        • Universitätsklinkum Giessen
      • Hamburg, Germany, 22763
        • Parxis Schofer, Mathey und Partner
      • Homburg/Saar, Germany, 66421
        • Universitätsklikum Homburg
      • Kassel, Germany, 34125
        • Klinikum Kassel
      • Leipzig, Germany, 04289
        • Herzzentrum - Universität Leipzig
      • Ludwigshafen, Germany, 67073
        • Herzzentrum Ludwigshafen
      • Mainz, Germany, 55131
        • Universitatsklinik Mainz
      • Mannheim, Germany, 68167
        • Universitätsklinikum Mannheim
      • Suhl, Germany, 98527
        • Zentralklinikum Suhl
      • Zürich, Switzerland, 8091
        • Universitätsspital Zürich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BMC
Intracoronary infusion of autologous bone marrow derived cells
Placebo Comparator: Placebo
Intracoronary infusion of Placebo medium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in global left ventricular function in quantitative LV angiography after 4 months.
Time Frame: baseline to 4 months
absolute delta LVEF (%)
baseline to 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary endpoint in patients without restenosis.
Time Frame: baseline to 4 months
absolute delta LVEF (%)
baseline to 4 months
Improvement of regional wall motion in infarct area
Time Frame: baseline to 4 months
baseline to 4 months
Reduction of LV end-systolic volume
Time Frame: baseline to 4 months
baseline to 4 months
Major adverse cardiac events (MACE)
Time Frame: at 4, 12 and 60 months
at 4, 12 and 60 months
Rehospitalization due to heart failure.
Time Frame: 4, 12, 60 months
4, 12, 60 months
NYHA status after 12 months
Time Frame: 12 months
12 months
Amendment for extended follow up after 2 and 5 years:
Time Frame: 24 and 60 months
24 and 60 months
outcomes in major adverse cardiac events (MACE)
Time Frame: 4, 12, 60 months
4, 12, 60 months
Rehospitalization due to heart failure
Time Frame: 4, 12, 60 months
4, 12, 60 months
NYHA status
Time Frame: 4, 12, 60 months
4, 12, 60 months
patients in MRI subgroup: improvement in left ventricular function
Time Frame: 4, 12, 60 months
4, 12, 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Andreas M Zeiher, MD, J. W. Goethe University Hospitals
  • Study Director: Volker Schächinger, MD, J. W. Goethe University Hopspitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

January 18, 2006

First Submitted That Met QC Criteria

January 18, 2006

First Posted (Estimate)

January 19, 2006

Study Record Updates

Last Update Posted (Estimate)

September 20, 2012

Last Update Submitted That Met QC Criteria

September 19, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • 2/04
  • Paul-Ehrlich-Institute 1034/01
  • EudraCT 2006-000250-43

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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