Meta-Analysis of Cell-based CaRdiac stUdiEs: ACCRUE

Ischemic Heart Disease Clinical Trial

— ACCRUE  

Official title:

Meta-Analysis of Cell-based CaRdiac stUdiEs: ACCRUE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01098591
• Other study ID #: MUW - Meta
• Status: Completed
• Start date: November 2007
• Est. completion date: December 2020

Study information

• Verified date: July 2021
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3500
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Other:
• cell therapy

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (27)

Lead Sponsor

Collaborator

Medical University of Vienna

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

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from occurrence of major adverse cardiac and cerebrovascular events (MACCE), including all-cause death, re-infarction, revascularization and stroke	MACCE is defined as all-cause death, re-infarction, revascularization and stroke	12 months
Secondary	Hard clinical end point	all-cause death, re-infarction and stroke	12 months
Secondary	Changes in end-diastolic volume	End-diastolic volume is an index of ventricular remodeling	12 months
Secondary	Changes in end-systolic volume	Index of ventricular systolic performance	12 months
Secondary	Changes in ejection fraction	Improvement of systolic cardiac function after cell therapy	12 months

External Links

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