NCT00711542

Brief Summary

Coronary flow reserve is an important measure of the integrity of the coronary microcirculation. Moreover, impaired coronary flow reserve is a predictor of future cardiovascular events and poor prognosis in patients after acute myocardial infarction. After acute myocardial infarction, coronary flow reserve remains significantly reduced. A previous randomized, double-blind Placebo-controlled trial (REPAIR-AMI) demonstrated complete normalization of coronary flow reserve after intracoronary application of autologous bone marrow-derived progenitor cells (but no effect in the placebo group) in patients with ST segment elevation myocardial infarction. The current study is planned to extend these findings to patients with Non-ST segment elevation myocardial infarction, since these patients have an equally reduced outcome.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for phase_1 coronary-artery-disease

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_1 coronary-artery-disease

Geographic Reach
1 country

2 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

July 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 9, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2017

Enrollment Period

6.3 years

First QC Date

July 8, 2008

Last Update Submit

January 11, 2017

Conditions

Coronary Artery DiseaseAcute Myocardial Infarction

Keywords

intracoronary progenitor cell therapyNSTEMIcoronary flow reserverandomized doubleblind Placebo-controlled trial

Outcome Measures

Primary Outcomes (1)

  • Improvement of coronary flow reserve in the infarct vessel

    4 months

Secondary Outcomes (4)

  • Improvement of relative coronary flow reserve

    4 months

  • Improvement of global and regional left ventricular ejection fraction

    4 months

  • Major adverse cardiac events (death, MI, rehospitalization for heart failure, revascularization)

    4 months

  • Major adverse cardiac events (death, MI, rehospitalization for heart failure, revascularization)

    12 months

Study Arms (2)

1

ACTIVE COMPARATOR

Intracoronary infusion of autologous bone marrow-derived progenitor cells after NSTEMI

Biological: autologous bone marrow-derived progenitor cells

2

PLACEBO COMPARATOR

Intracoronary infusion of Placebo after NSTEMI

Biological: placebo medium

Interventions

autologous bone marrow-derived progenitor cellsBIOLOGICAL

intracoronary infusion of autologous bone marrow-derived progenitor cells isolated from 50 ml bone marrow aspirate

1
placebo mediumBIOLOGICAL

intracoronary infusion of placebo medium

2

Eligibility Criteria

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

You may qualify if:

  • Patients with acute coronary syndrome (ST-depression in at least 2 leads \> 0,1 mV), or T-wave inversion, with or without elevated myocardial biomarkers (Troponin T oder I), together with typical clinical presentation), treated as follows:
  • Acute percutaneous revascularization with stent implantation within 48 hours after symptom onset.
  • Successful acute PCI (residual stenosis \< 30%, TIMI flow \> 2).
  • Hemodynamic stability
  • Age 18 - 80 years
  • Written informed consent
  • Active contraception in women of childbearing age

You may not qualify if:

  • Patients with STEMI (ST elevation in 2 leads above 0,2 mV in lead V1, V2 oder V3 or above 0,1 mV in the other leads)
  • Necessity of additional PCI in non-infarct vessel at the time of study therapy (multi-vessel PCI in the acute event is possible)
  • Heart failure (LVEF ≤ 30 %).
  • Arteriovenous malformation or aneurysms
  • Active infection (C-reactive protein \> 10 mg/dl), or fever, or diarrhoea within the last 4 weeks
  • Chronic inflammatory disease
  • HIV infection or active hepatitis
  • Neoplastic disease without documented complete remission within the last 5 years
  • Recent stroke within the last 3 months
  • Impaired kidney function (creatinin \> 2,5 mg/dl) at the time of treatment
  • Significant liver disease (GOT \> 2x upper normal value or spontaneous INR \> 1,5.
  • Hematopoetic disease (anaemia with Hb\< 8.5 mg/dl; thrombocytopenia \< 100.000/µl; splenomegaly
  • Known allergies to Clopidogrel, Heparin or Abciximab
  • History of bleeding disorder
  • GI bleeding within the last 3 months
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Med. Klinik III; Kardiologie

Frankfurt, 60590, Germany

Location

Universität Leipzig / Herzzentrum

Leipzig, 04289, Germany

Location

Related Publications (7)

  • 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: 17620510BACKGROUND

  • 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: 17098754BACKGROUND

  • 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: 16990384BACKGROUND

  • Dimmeler S, Burchfield J, Zeiher AM. Cell-based therapy of myocardial infarction. Arterioscler Thromb Vasc Biol. 2008 Feb;28(2):208-16. doi: 10.1161/ATVBAHA.107.155317. Epub 2007 Oct 19.

    PMID: 17951319BACKGROUND

  • Schachinger V, Assmus B, Honold J, Lehmann R, Hofmann WK, Martin H, Dimmeler S, Zeiher AM. Normalization of coronary blood flow in the infarct-related artery after intracoronary progenitor cell therapy: intracoronary Doppler substudy of the TOPCARE-AMI trial. Clin Res Cardiol. 2006 Jan;95(1):13-22. doi: 10.1007/s00392-006-0314-x.

    PMID: 16598441BACKGROUND

  • Schachinger V, Assmus B, Britten MB, Honold J, Lehmann R, Teupe C, Abolmaali ND, Vogl TJ, Hofmann WK, Martin H, Dimmeler S, Zeiher AM. Transplantation of progenitor cells and regeneration enhancement in acute myocardial infarction: final one-year results of the TOPCARE-AMI Trial. J Am Coll Cardiol. 2004 Oct 19;44(8):1690-9. doi: 10.1016/j.jacc.2004.08.014.

    PMID: 15489105BACKGROUND

  • Assmus B, Schachinger V, Teupe C, Britten M, Lehmann R, Dobert N, Grunwald F, Aicher A, Urbich C, Martin H, Hoelzer D, Dimmeler S, Zeiher AM. Transplantation of Progenitor Cells and Regeneration Enhancement in Acute Myocardial Infarction (TOPCARE-AMI). Circulation. 2002 Dec 10;106(24):3009-17. doi: 10.1161/01.cir.0000043246.74879.cd.

    PMID: 12473544BACKGROUND

MeSH Terms

Conditions

Coronary Artery DiseaseNon-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesMyocardial InfarctionInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Andreas M Zeiher, MD

    Goethe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Andreas M. Zeiher

Study Record Dates

First Submitted

July 8, 2008

First Posted

July 9, 2008

Study Start

September 1, 2008

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

January 12, 2017

Record last verified: 2017-01

Locations

DE(2)