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

July 12, 2021 updated by: Mariann Gyongyosi, Medical University of Vienna
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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

3500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2007

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

March 30, 2010

First Submitted That Met QC Criteria

April 2, 2010

First Posted (Estimate)

April 5, 2010

Study Record Updates

Last Update Posted (Actual)

July 13, 2021

Last Update Submitted That Met QC Criteria

July 12, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ischemic Heart Disease

Clinical Trials on cell therapy

3
Subscribe