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

Last updated: September 19, 2012
Sponsor: A. M. Zeiher
Overall Status: Completed

Phase

3

Condition

Congestive Heart Failure

Heart Defect

Coronary Artery Disease

Treatment

N/A

Clinical Study ID

NCT00279175
2/04
EudraCT 2006-000250-43
Paul-Ehrlich-Institute 1034/01
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with acute myocardial infarction (ST elevation in at least 2 leads >= 0.2 mVin V1,V2 or V3 or >= 0.1 mV in other leads), treated by one of the followingprocedures

  • 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 withstent 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 ormechanical 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

Exclusion Criteria:

  • Regional wall motion abnormality outside the area involved in the index acutemyocardial 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 Design

Total Participants: 204
Study Start date:
April 01, 2004
Estimated Completion Date:
December 31, 2010

Study 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.

Connect with a study center

  • Zentralklinik Bad Berka

    Bad Berka, 99437
    Germany

    Site Not Available

  • Kerckhoff Klinik

    Bad Nauheim, 61231
    Germany

    Site Not Available

  • Herz- und Diabeteszentrum NRW

    Bad Oeynhausen, 32545
    Germany

    Site Not Available

  • BG Kliniken Bergmannsheil

    Bochum, 44789
    Germany

    Site Not Available

  • Klinikum Lippe

    Detmold, 32756
    Germany

    Site Not Available

  • J. W. Goethe University Hospitals

    Frankfurt, 60590
    Germany

    Site Not Available

  • Rotes-Kreuz Krankenhaus - Kardiologisches Centrum

    Frankfurt, 60316
    Germany

    Site Not Available

  • Universitätsklinkum Giessen

    Giessen, 35392
    Germany

    Site Not Available

  • Parxis Schofer, Mathey und Partner

    Hamburg, 22763
    Germany

    Site Not Available

  • Universitätsklikum Homburg

    Homburg/Saar, 66421
    Germany

    Site Not Available

  • Klinikum Kassel

    Kassel, 34125
    Germany

    Site Not Available

  • Herzzentrum - Universität Leipzig

    Leipzig, 04289
    Germany

    Site Not Available

  • Herzzentrum Ludwigshafen

    Ludwigshafen, 67073
    Germany

    Site Not Available

  • Universitätsklinik Mainz

    Mainz, 55131
    Germany

    Site Not Available

  • Universitätsklinikum Mannheim

    Mannheim, 68167
    Germany

    Site Not Available

  • Zentralklinikum Suhl

    Suhl, 98527
    Germany

    Site Not Available

  • Universitätsspital Zürich

    Zürich, 8091
    Switzerland

    Site Not Available

  • Universitätsspital Zürich

    Zürich, 8091
    Switzerland

    Site Not Available

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