Meta-Analysis of Cell-based CaRdiac stUdiEs: ACCRUE

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 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
Information provided by (Responsible Party):
Mariann Gyongyosi, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01098591
First received: March 30, 2010
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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 Intervention
Ischemic Heart Disease
Other: cell therapy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Meta-Analysis of Cell-based CaRdiac stUdiEs: ACCRUE

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 1000
Study Start Date: November 2007
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
  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: NCT01098591

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

Locations
Austria
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
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
Investigators
Principal Investigator: Mariann Gyongyosi, MD Medical University of Vienna
  More Information

No publications provided

Responsible Party: Mariann Gyongyosi, MD PhD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01098591     History of Changes
Other Study ID Numbers: MUW - Meta
Study First Received: March 30, 2010
Last Updated: July 16, 2014
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
meta-analysis
stem cell
cardiac
remodeling
MESS

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

ClinicalTrials.gov processed this record on July 22, 2014