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NCT Number: NCT01098591

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.

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Key information

Conditions

Ischemic Heart Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna

Vienna, 1090, Austria

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Cell therapy

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

  • Asklepios Kliniken Hamburg GmbH
  • Cedars-Sinai Medical Center
  • Hannover Medical School
  • Heinrich-Heine University, Duesseldorf
  • Johann Wolfgang Goethe University Hospital
  • Karolinska Institutet
  • Klinik Hirslanden, Zurich
  • Leiden University Medical Center
  • Medical University of Silesia
  • Military Medical Academy, Belgrade, Serbia
  • Minneapolis Heart Institute
  • Nantes University Hospital
  • Novosibirsk Scientific Research Institute for Circulatory Pathology
  • Odense University Hospital
  • Oslo University Hospital
  • Rigshospitalet, Denmark
  • State Health Center, Hungary
  • The University of Texas Health Science Center, Houston
  • University Clinic for Cardiology, Skopje, Republic of Macedonia
  • University Hospital, Toulouse
  • University of Debrecen
  • University of Oulu
  • University of Targu Mures, Romania
  • University of Ulm
  • University of Zurich
  • VZW Cardiovascular Research Center Aalst

Registry information

Acronym: ACCRUE

Important dates

Study start
2007
Primary completion
2020
Study completion
2020
First posted
Apr 5, 2010
Registry last updated
Jul 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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