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Effects of Intracoronary Progenitor Cell Therapy on Coronary Flow Reserve After Acute MI (REPAIR-ACS)

This study has been terminated.
(Slow recruitment)
Sponsor:
Collaborator:
University of Leipzig
Information provided by (Responsible Party):
A. M. Zeiher, Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier:
NCT00711542
First received: July 8, 2008
Last updated: January 11, 2017
Last verified: January 2017
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease Acute Myocardial Infarction Biological: autologous bone marrow-derived progenitor cells Biological: placebo medium Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reinfusion of Enriched Progenitor Cells And Infarct Remodeling in Acute Coronary Syndrome: REPAIR - ACS

Further study details as provided by A. M. Zeiher, Johann Wolfgang Goethe University Hospital:

Primary Outcome Measures:
  • Improvement of coronary flow reserve in the infarct vessel [ Time Frame: 4 months ]

Secondary Outcome Measures:
  • Improvement of relative coronary flow reserve [ Time Frame: 4 months ]
  • Improvement of global and regional left ventricular ejection fraction [ Time Frame: 4 months ]
  • Major adverse cardiac events (death, MI, rehospitalization for heart failure, revascularization) [ Time Frame: 4 months ]
  • Major adverse cardiac events (death, MI, rehospitalization for heart failure, revascularization) [ Time Frame: 12 months ]

Enrollment: 31
Study Start Date: September 2008
Study Completion Date: December 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Intracoronary infusion of autologous bone marrow-derived progenitor cells after NSTEMI
Biological: autologous bone marrow-derived progenitor cells
intracoronary infusion of autologous bone marrow-derived progenitor cells isolated from 50 ml bone marrow aspirate
Placebo Comparator: 2
Intracoronary infusion of Placebo after NSTEMI
Biological: placebo medium
intracoronary infusion of placebo medium

Detailed Description:

Improvement of neovascularization is a key mechanism of functional improvement of intracoronary application of progenitor cells after acute myocardial infarction. Since capillary density cannot be assessed histological in patients, measurement of coronary flow reserve is an exact means for estimating capillary density and assessing coronary microvascular function. With the help of an intracoronary Doppler Wire, coronary hemodynamics can be assessed at baseline and, for example, adenosin-induced maximal vasodilation. Calculation of the minimal vascular resistance indices allows to estimate the cross-sectional area, reflecting capillary density, and, in comparison with the time of the acute myocardial infarction, estimation of improved neovascularization at a later timepoint.

In order to improve neovascularization, which may then be associated with improved left ventricular contractility, we initiated the current trial.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • Major surgery or trauma within the last 2 months
  • Uncontrolled hypertension
  • Pregnancy
  • Mental disability
  • Previous progenitor cell therapy
  • Participation in a different 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: NCT00711542

Locations
Germany
Med. Klinik III; Kardiologie
Frankfurt, Germany, 60590
Universität Leipzig / Herzzentrum
Leipzig, Germany, 04289
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
University of Leipzig
Investigators
Principal Investigator: Andreas M Zeiher, MD Goethe University
  More Information

Additional Information:
Publications:

Responsible Party: A. M. Zeiher, Prof. Dr. Andreas M. Zeiher, Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT00711542     History of Changes
Other Study ID Numbers: 2007-08-16 REPAIR-ACS
Study First Received: July 8, 2008
Last Updated: January 11, 2017

Keywords provided by A. M. Zeiher, Johann Wolfgang Goethe University Hospital:
intracoronary progenitor cell therapy
NSTEMI
coronary flow reserve
randomized doubleblind Placebo-controlled trial

Additional relevant MeSH terms:
Infarction
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on June 28, 2017