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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 26, 2014