Meta-Analysis of Cell-based CaRdiac stUdiEs: ACCRUE

NCT ID: NCT01098591

Last Updated: 2021-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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* 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.

Conditions

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Ischemic Heart Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Myocardial infarction

Patients with post-myocardial infarction receiving cell therapy either intracoronarily or intramyocardial

cell therapy

Intervention Type OTHER

Ischemic cardiomyopathy

Patients with ischemic cardiomyopathy treated with cell therapy either intracoronarily or intramyocardial

cell therapy

Intervention Type OTHER

Interventions

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cell therapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role collaborator

Medical University of Silesia

OTHER

Sponsor Role collaborator

Hannover Medical School

OTHER

Sponsor Role collaborator

VZW Cardiovascular Research Center Aalst

OTHER

Sponsor Role collaborator

Cedars-Sinai Medical Center

OTHER

Sponsor Role collaborator

Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role collaborator

University of Ulm

OTHER

Sponsor Role collaborator

Military Medical Academy, Belgrade, Serbia

OTHER

Sponsor Role collaborator

Novosibirsk Scientific Research Institute for Circulatory Pathology

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Asklepios Kliniken Hamburg GmbH

OTHER

Sponsor Role collaborator

Leiden University Medical Center

OTHER

Sponsor Role collaborator

University of Debrecen

OTHER

Sponsor Role collaborator

University of Targu Mures, Romania

OTHER

Sponsor Role collaborator

University Clinic for Cardiology, Skopje, Republic of Macedonia

UNKNOWN

Sponsor Role collaborator

State Health Center, Hungary

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role collaborator

University of Oulu

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role collaborator

Minneapolis Heart Institute

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role collaborator

Klinik Hirslanden, Zurich

OTHER

Sponsor Role collaborator

University Hospital, Toulouse

OTHER

Sponsor Role collaborator

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role collaborator

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Mariann Gyongyosi

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mariann Gyongyosi, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

References

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Gyongyosi M, Wojakowski W, Lemarchand P, Lunde K, Tendera M, Bartunek J, Marban E, Assmus B, Henry TD, Traverse JH, Moye LA, Surder D, Corti R, Huikuri H, Miettinen J, Wohrle J, Obradovic S, Roncalli J, Malliaras K, Pokushalov E, Romanov A, Kastrup J, Bergmann MW, Atsma DE, Diederichsen A, Edes I, Benedek I, Benedek T, Pejkov H, Nyolczas N, Pavo N, Bergler-Klein J, Pavo IJ, Sylven C, Berti S, Navarese EP, Maurer G; ACCRUE Investigators. Meta-Analysis of Cell-based CaRdiac stUdiEs (ACCRUE) in patients with acute myocardial infarction based on individual patient data. Circ Res. 2015 Apr 10;116(8):1346-60. doi: 10.1161/CIRCRESAHA.116.304346. Epub 2015 Feb 19.

Reference Type DERIVED
PMID: 25700037 (View on PubMed)

Related Links

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Other Identifiers

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MUW - Meta

Identifier Type: -

Identifier Source: org_study_id

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