Meta-Analysis of Cell-based CaRdiac stUdiEs: ACCRUE

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT01098591

Collaborator

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

3,500

Enrollment

Location

157

Actual Duration (Months)

22.3

Patients Per Site Per Month

Study Details

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	Phase
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

Actual Enrollment :

3500 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Meta-Analysis of Cell-based CaRdiac stUdiEs: ACCRUE

Actual Study Start Date :

Nov 1, 2007

Actual Primary Completion Date :

Dec 1, 2020

Actual Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	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

Arm

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

Freedom from occurrence of major adverse cardiac and cerebrovascular events (MACCE), including all-cause death, re-infarction, revascularization and stroke [12 months]
MACCE is defined as all-cause death, re-infarction, revascularization and stroke

Secondary Outcome Measures

Hard clinical end point [12 months]
all-cause death, re-infarction and stroke
Changes in end-diastolic volume [12 months]
End-diastolic volume is an index of ventricular remodeling
Changes in end-systolic volume [12 months]
Index of ventricular systolic performance
Changes in ejection fraction [12 months]
Improvement of systolic cardiac function after cell therapy