CompletedNCT01098591ACCRUEUpdated Jul 13, 2021

Meta-Analysis of Cell-based CaRdiac stUdiEs: ACCRUE

An observational study in Ischemic Heart Disease, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-07-13.

Sponsored by Medical University of Vienna · Observational

Study type: Observational
Model: Case-only
Time perspective: Retrospective
Enrollment: 3,500
Ages: 18 Years to 80 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Ischemic Heart Disease

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Keywords

meta-analysis
stem cell
cardiac
remodeling
ACCRUE

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 3,500 is above the median of 294 across 1,241 observational studies indexed under Heart Diseases.

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Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

none

Study design

Observational model: Case-only
Time perspective: Retrospective
Enrollment: 3,500 participants (actual)
Patient registry: No

Groups and cohorts

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

Interventions

Othercell therapy

What researchers measure

Primary outcomes

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
Time frame: 12 months

Secondary outcomes

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

Study locations

1 site

Medical University of Vienna
Vienna, 1090, Austria

References and documents

Publications

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. PubMed 25700037 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01098591
Lead sponsor: Medical University of Vienna
Collaborators: Nantes University Hospital, Oslo University Hospital, Medical University of Silesia, Hannover Medical School, VZW Cardiovascular Research Center Aalst, Cedars-Sinai Medical Center, Johann Wolfgang Goethe University Hospital, University of Ulm, Military Medical Academy, Belgrade, Serbia, Novosibirsk Scientific Research Institute for Circulatory Pathology, Rigshospitalet, Denmark, Asklepios Kliniken Hamburg GmbH, Leiden University Medical Center, University of Debrecen, University of Targu Mures, Romania, University Clinic for Cardiology, Skopje, Republic of Macedonia, State Health Center, Hungary, Karolinska Institutet, University of Zurich, University of Oulu, Odense University Hospital, Minneapolis Heart Institute, The University of Texas Health Science Center, Houston, Klinik Hirslanden, Zurich, University Hospital, Toulouse, Heinrich-Heine University, Duesseldorf
Responsible party: Mariann Gyongyosi (MD PhD, Medical University of Vienna) — Principal investigator
First posted: Apr 5, 2010
Start date: Nov 2007
Primary completion: Dec 2020
Completion: Dec 2020
Last update: Jul 13, 2021

Study contacts

Mariann Gyongyosi, MD

principal investigator · Medical University of Vienna

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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