NCT00279175

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2004

Longer than P75 for phase_3

Geographic Reach
2 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2006

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

September 20, 2012

Status Verified

September 1, 2012

Enrollment Period

1.5 years

First QC Date

January 18, 2006

Last Update Submit

September 19, 2012

Conditions

Myocardial Infarction

Keywords

Acute myocardial infarction

Outcome Measures

Primary Outcomes (1)

  • Change in global left ventricular function in quantitative LV angiography after 4 months.

    absolute delta LVEF (%)

    baseline to 4 months

Secondary Outcomes (11)

  • Primary endpoint in patients without restenosis.

    baseline to 4 months

  • Improvement of regional wall motion in infarct area

    baseline to 4 months

  • Reduction of LV end-systolic volume

    baseline to 4 months

  • Major adverse cardiac events (MACE)

    at 4, 12 and 60 months

  • Rehospitalization due to heart failure.

    4, 12, 60 months

  • +6 more secondary outcomes

Study Arms (2)

BMC

EXPERIMENTAL

Intracoronary infusion of autologous bone marrow derived cells

Biological: Intracoronary infusion of enriched bone marrow-derived progenitor cells

Placebo

PLACEBO COMPARATOR

Intracoronary infusion of Placebo medium

Biological: Placebo medium supplemented with autologous serum

Interventions

Intracoronary infusion of enriched bone marrow-derived progenitor cellsBIOLOGICAL
BMC
Placebo medium supplemented with autologous serumBIOLOGICAL
Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • 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

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Zentralklinik Bad Berka

Bad Berka, 99437, Germany

Location

Kerckhoff Klinik

Bad Nauheim, 61231, Germany

Location

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, 32545, Germany

Location

BG Kliniken Bergmannsheil

Bochum, 44789, Germany

Location

Klinikum Lippe

Detmold, 32756, Germany

Location

Rotes-Kreuz Krankenhaus - Kardiologisches Centrum

Frankfurt, 60316, Germany

Location

J. W. Goethe University Hospitals

Frankfurt, 60590, Germany

Location

Universitätsklinkum Giessen

Giessen, 35392, Germany

Location

Parxis Schofer, Mathey und Partner

Hamburg, 22763, Germany

Location

Universitätsklikum Homburg

Homburg/Saar, 66421, Germany

Location

Klinikum Kassel

Kassel, 34125, Germany

Location

Herzzentrum - Universität Leipzig

Leipzig, 04289, Germany

Location

Herzzentrum Ludwigshafen

Ludwigshafen, 67073, Germany

Location

Universitätsklinik Mainz

Mainz, 55131, Germany

Location

Universitätsklinikum Mannheim

Mannheim, 68167, Germany

Location

Zentralklinikum Suhl

Suhl, 98527, Germany

Location

Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

Related Publications (8)

  • Schachinger V, Tonn T, Dimmeler S, Zeiher AM. Bone-marrow-derived progenitor cell therapy in need of proof of concept: design of the REPAIR-AMI trial. Nat Clin Pract Cardiovasc Med. 2006 Mar;3 Suppl 1:S23-8. doi: 10.1038/ncpcardio0441.

    PMID: 16501626BACKGROUND

  • Schachinger V, Erbs S, Elsasser A, Haberbosch W, Hambrecht R, Holschermann H, Yu J, Corti R, Mathey DG, Hamm CW, Suselbeck T, Assmus B, Tonn T, Dimmeler S, Zeiher AM; REPAIR-AMI Investigators. Intracoronary bone marrow-derived progenitor cells in acute myocardial infarction. N Engl J Med. 2006 Sep 21;355(12):1210-21. doi: 10.1056/NEJMoa060186.

    PMID: 16990384RESULT

  • Schachinger V, Erbs S, Elsasser A, Haberbosch W, Hambrecht R, Holschermann H, Yu J, Corti R, Mathey DG, Hamm CW, Suselbeck T, Werner N, Haase J, Neuzner J, Germing A, Mark B, Assmus B, Tonn T, Dimmeler S, Zeiher AM; REPAIR-AMI Investigators. Improved clinical outcome after intracoronary administration of bone-marrow-derived progenitor cells in acute myocardial infarction: final 1-year results of the REPAIR-AMI trial. Eur Heart J. 2006 Dec;27(23):2775-83. doi: 10.1093/eurheartj/ehl388. Epub 2006 Nov 10.

    PMID: 17098754RESULT

  • Dill T, Schachinger V, Rolf A, Mollmann S, Thiele H, Tillmanns H, Assmus B, Dimmeler S, Zeiher AM, Hamm C. Intracoronary administration of bone marrow-derived progenitor cells improves left ventricular function in patients at risk for adverse remodeling after acute ST-segment elevation myocardial infarction: results of the Reinfusion of Enriched Progenitor cells And Infarct Remodeling in Acute Myocardial Infarction study (REPAIR-AMI) cardiac magnetic resonance imaging substudy. Am Heart J. 2009 Mar;157(3):541-7. doi: 10.1016/j.ahj.2008.11.011. Epub 2009 Jan 31.

    PMID: 19249426RESULT

  • Erbs S, Linke A, Schachinger V, Assmus B, Thiele H, Diederich KW, Hoffmann C, Dimmeler S, Tonn T, Hambrecht R, Zeiher AM, Schuler G. Restoration of microvascular function in the infarct-related artery by intracoronary transplantation of bone marrow progenitor cells in patients with acute myocardial infarction: the Doppler Substudy of the Reinfusion of Enriched Progenitor Cells and Infarct Remodeling in Acute Myocardial Infarction (REPAIR-AMI) trial. Circulation. 2007 Jul 24;116(4):366-74. doi: 10.1161/CIRCULATIONAHA.106.671545. Epub 2007 Jul 9.

    PMID: 17620510RESULT

  • Assmus B, Rolf A, Erbs S, Elsasser A, Haberbosch W, Hambrecht R, Tillmanns H, Yu J, Corti R, Mathey DG, Hamm CW, Suselbeck T, Tonn T, Dimmeler S, Dill T, Zeiher AM, Schachinger V; REPAIR-AMI Investigators. Clinical outcome 2 years after intracoronary administration of bone marrow-derived progenitor cells in acute myocardial infarction. Circ Heart Fail. 2010 Jan;3(1):89-96. doi: 10.1161/CIRCHEARTFAILURE.108.843243. Epub 2009 Dec 8.

    PMID: 19996415RESULT

  • Rolf A, Assmus B, Schachinger V, Rixe J, Mollmann S, Mollmann H, Dimmeler S, Zeiher AM, Hamm CW, Dill T. Maladaptive hypertrophy after acute myocardial infarction positive effect of bone marrow-derived stem cell therapy on regional remodeling measured by cardiac MRI. Clin Res Cardiol. 2011 Nov;100(11):983-92. doi: 10.1007/s00392-011-0330-3. Epub 2011 Jun 17.

    PMID: 21681619DERIVED

  • Assmus B, Tonn T, Seeger FH, Yoon CH, Leistner D, Klotsche J, Schachinger V, Seifried E, Zeiher AM, Dimmeler S. Red blood cell contamination of the final cell product impairs the efficacy of autologous bone marrow mononuclear cell therapy. J Am Coll Cardiol. 2010 Mar 30;55(13):1385-94. doi: 10.1016/j.jacc.2009.10.059.

    PMID: 20338501DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Andreas M Zeiher, MD

    J. W. Goethe University Hospitals

    PRINCIPAL INVESTIGATOR

  • Volker Schächinger, MD

    J. W. Goethe University Hopspitals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor Dr. med.

Study Record Dates

First Submitted

January 18, 2006

First Posted

January 19, 2006

Study Start

April 1, 2004

Primary Completion

October 1, 2005

Study Completion

December 1, 2010

Last Updated

September 20, 2012

Record last verified: 2012-09

Locations

CH(1)DE(16)