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Meta-Analysis of Cell-based CaRdiac stUdiEs: ACCRUE (ACCRUE)

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ClinicalTrials.gov Identifier: NCT01098591
Recruitment Status : Unknown
Verified March 2015 by Mariann Gyongyosi, Medical University of Vienna.
Recruitment status was:  Recruiting
First Posted : April 5, 2010
Last Update Posted : March 3, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Ischemic Heart Disease Other: cell therapy

Detailed Description:
  • 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.

Study Design

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Meta-Analysis of Cell-based CaRdiac stUdiEs: ACCRUE
Study Start Date : November 2007
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015
Groups and Cohorts

Group/Cohort Intervention/treatment
Myocardial infarction
Patients with post-myocardial infarction receiving cell therapy either intracoronarily or intramyocardial
Other: cell therapy
Ischemic cardiomyopathy
Patients with ischemic cardiomyopathy treated with cell therapy either intracoronarily or intramyocardial
Other: cell therapy

Outcome Measures

Primary Outcome Measures :
  1. Freedom from occurrence of major adverse cardiac and cerebrovascular events (MACCE), including all-cause death, re-infarction, revascularization and stroke [ Time Frame: 12 months ]
    MACCE is defined as all-cause death, re-infarction, revascularization and stroke

Secondary Outcome Measures :
  1. Hard clinical end point [ Time Frame: 12 months ]
    all-cause death, re-infarction and stroke

  2. Changes in end-diastolic volume [ Time Frame: 12 months ]
    End-diastolic volume is an index of ventricular remodeling

  3. Changes in end-systolic volume [ Time Frame: 12 months ]
    Index of ventricular systolic performance

  4. Changes in ejection fraction [ Time Frame: 12 months ]
    Improvement of systolic cardiac function after cell therapy

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated with cell-based cardiac therapy at one of the participating centers

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01098591

Contact: Mariann Gyongyosi, MD mariann.gyongyosi@meduniwien.ac.at

Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Mariann Gyöngyösi, MD       mariann.gyongyosi@meduniwien.ac.at   
Contact: Mariann Gyöngyösi         
Sponsors and Collaborators
Medical University of Vienna
Nantes University Hospital
Oslo University Hospital
Medical University of Silesia
Hannover Medical School
VZW Cardiovascular Research Center Aalst
Cedars-Sinai Medical Center
Johann Wolfgang Goethe University Hospital
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
Odense University Hospital
Minneapolis Heart Institute
The University of Texas Health Science Center, Houston
Klinik Hirslanden, Zurich
University Hospital, Toulouse
Heinrich-Heine University, Duesseldorf
Principal Investigator: Mariann Gyongyosi, MD Medical University of Vienna
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mariann Gyongyosi, MD PhD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01098591     History of Changes
Other Study ID Numbers: MUW - Meta
First Posted: April 5, 2010    Key Record Dates
Last Update Posted: March 3, 2015
Last Verified: March 2015

Keywords provided by Mariann Gyongyosi, Medical University of Vienna:
stem cell

Additional relevant MeSH terms:
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases