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

This study has been completed.
Sponsor:
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
History of Changes

January 18, 2006
September 19, 2012
April 2004
October 2005   (final data collection date for primary outcome measure)
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 (%)
Change in global left ventricular function in quantitative LV angiography after 4 months.
Complete list of historical versions of study NCT00279175 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Primary endpoint in patients without restenosis.
  • Improvement of regional wall motion in infarct area
  • Reduction of LV end-systolic volume
  • Major adverse cardiac events (MACE)
  • Rehospitalization due to heart failure.
  • NYHA status after 12 months
Not Provided
Not Provided
 
REPAIR-AMI: Intracoronary Progenitor Cells in Acute Myocardial Infarction (AMI)
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.
  • 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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Myocardial Infarction
  • Biological: Intracoronary infusion of enriched bone marrow-derived progenitor cells
  • Biological: Placebo medium supplemented with autologous serum
  • Experimental: BMC
    Intracoronary infusion of autologous bone marrow derived cells
    Intervention: Biological: Intracoronary infusion of enriched bone marrow-derived progenitor cells
  • Placebo Comparator: Placebo
    Intracoronary infusion of Placebo medium
    Intervention: Biological: Placebo medium supplemented with autologous serum

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
204
December 2010
October 2005   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Switzerland
 
NCT00279175
2/04, Paul-Ehrlich-Institute 1034/01, EudraCT 2006-000250-43
Not Provided
A. M. Zeiher, Johann Wolfgang Goethe University Hospitals
A. M. Zeiher
  • Johann Wolfgang Goethe University Hospitals
  • Blutspendedienst Baden-Württemberg - Hessen
  • Guidant Corporation
  • Eli Lilly and Company
Principal Investigator: Andreas M Zeiher, MD J. W. Goethe University Hospitals
Study Director: Volker Schächinger, MD J. W. Goethe University Hopspitals
Johann Wolfgang Goethe University Hospitals
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP