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Meta-Analysis of Cell-based CaRdiac stUdiEs: ACCRUE

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Medical University of Vienna
Sponsor:
Collaborators:
Nantes University Hospital
Oslo University Hospital
Medical University of Silesia
Hannover Medical School
Cardiovascular Research Center, Aalst, Belgium
Cedars-Sinai Medical Center
Johann Wolfgang Goethe University Hospitals
University of Ulm
Military Medical Academy, Belgrade, Serbia
Novosibirsk Scientific Research Institute for Circulatory Pathology
Rigshospitalet, Denmark
Asklepios Kliniken Hamburg GmbH
Leiden University Medical Center
University of Debrecen
University of Targu Mures, Romania
University Clinic for Cardiology, Skopje, Republic of Macedonia
State Health Center, Hungary
Karolinska Institutet
University of Zurich
University of Oulu
Cardiovascular Cell Therapy Research Network
Odense University Hospital
Information provided by (Responsible Party):
Mariann Gyongyosi, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01098591
First received: March 30, 2010
Last updated: August 24, 2014
Last verified: August 2014

March 30, 2010
August 24, 2014
November 2007
December 2015   (final data collection date for primary outcome measure)
Freedom from occurrence of major adverse cardiac and cerebrovascular events (MACCE), including all-cause death, re-infarction, revascularization and stroke [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
MACCE is defined as all-cause death, re-infarction, revascularization and stroke
Left ventricular ejection fraction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change of global left ventricular funtion 3-6 month after cardiac stem cell therapy
Complete list of historical versions of study NCT01098591 on ClinicalTrials.gov Archive Site
  • Hard clinical end point [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    all-cause death, re-infarction and stroke
  • Changes in end-diastolic volume [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    End-diastolic volume is an index of ventricular remodeling
  • Changes in end-systolic volume [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Index of ventricular systolic performance
  • Changes in ejection fraction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Improvement of systolic cardiac function after cell therapy
  • Infarct size [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Decrease of infarct size 3-6 months after cardiac stem cell therapy
  • Canadian Cardiovascular Society (CCS) Classification of angina pectoris [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Improvement of clinical angina status
  • Major adverse cardiac and cerebrovascular events (MACCE) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Occurrence of major adverse cardiac and cerebrovascular events after cardiac stem cell therapy
  • New York Heart Association (NYHA) Functional Classification of Heart Insufficiency [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Improvement of NYHA 3-6 months after cardiac stem cell therapy
Not Provided
Not Provided
 
Meta-Analysis of Cell-based CaRdiac stUdiEs: ACCRUE
Meta-Analysis of Cell-based CaRdiac stUdiEs: ACCRUE

Numerous human cardiac stem cell studies have been published, including relatively small number of patients. Meta-analysis of randomized trials have reported safety and a 3-6% increase in global left ventricular performance after intracoronary stem cell therapy in patients with acute myocardial infarction. Since most of the studies used different type of stem cells, delivery modes, and patient population, the results are heterogenous, therefore the comparison of the results is biased regarding generalizable conclusions about the effect of treatment. The present comparative meta-analysis is based on individual patient data, and gathers and pools the raw data, and analyzes the clinical outcome, safety and efficacy of the cardiac stem cell therapy.

  • Background: Many clinical trials and meta-analyses presented moderate but significant improvement of the left ventricular ejection fraction (LVEF) after intracoronary autologous bone-marrow (BM) or peripheral blood origin stem cells transfer. However, it remains controversial, whether this beneficial effects is comparable with the intramyocardial delivery of the stem cells, or could be maintained during moderate and long term follow-up. The BOOST trial suggested that cardiac stem cell therapy did not improve LVEF at 5-year follow-up. By contrast, BALANCE study showed a long sustained benefit of BM-stem cells treatment. Due to these divergent outcomes of the presented trials, the aim of the present meta-analysis is to compare the safety and effectiveness of the cardiac stem cell therapy in different patient population, delivery mode and cell type, to find out, which patients with which therapy mode can have the greatest benefit from cardiac stem cell therapy.
  • Study design: individual patient data meta-analysis
  • Data sources: European Centre performing human cardiac stem cell therapy have been contacted calling for participation.
  • Methods: Individual data gathering and entering into the database for a pooled analysis. The meta-analysis will be done in line with recommendation from the Cochrane Collaboration and the Quality of Reporting of Meta-analyses guidelines with Review Manager 5.0. Fixed-effect model will be used.
Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

Patients treated with cell-based cardiac therapy at one of the participating centers

Ischemic Heart Disease
Other: cell therapy
  • Myocardial infarction
    Patients with post-myocardial infarction receiving cell therapy either intracoronarily or intramyocardial
    Intervention: Other: cell therapy
  • Ischemic cardiomyopathy
    Patients with ischemic cardiomyopathy treated with cell therapy either intracoronarily or intramyocardial
    Intervention: Other: cell therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patient included in one of the registered cell-based cardiac therapy of the participating center

Exclusion Criteria:

  • none
Both
18 Years to 80 Years
No
Contact: Mariann Gyongyosi, MD mariann.gyongyosi@meduniwien.ac.at
Austria
 
NCT01098591
MUW - Meta
No
Mariann Gyongyosi, Medical University of Vienna
Medical University of Vienna
  • Nantes University Hospital
  • Oslo University Hospital
  • Medical University of Silesia
  • Hannover Medical School
  • Cardiovascular Research Center, Aalst, Belgium
  • Cedars-Sinai Medical Center
  • Johann Wolfgang Goethe University Hospitals
  • University of Ulm
  • Military Medical Academy, Belgrade, Serbia
  • Novosibirsk Scientific Research Institute for Circulatory Pathology
  • Rigshospitalet, Denmark
  • Asklepios Kliniken Hamburg GmbH
  • Leiden University Medical Center
  • University of Debrecen
  • University of Targu Mures, Romania
  • University Clinic for Cardiology, Skopje, Republic of Macedonia
  • State Health Center, Hungary
  • Karolinska Institutet
  • University of Zurich
  • University of Oulu
  • Cardiovascular Cell Therapy Research Network
  • Odense University Hospital
Principal Investigator: Mariann Gyongyosi, MD Medical University of Vienna
Medical University of Vienna
August 2014

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