Clinical trial NCT01098591: Meta-Analysis of Cell-based CaRdiac stUdiEs: ACCRUE
Official title: Meta-Analysis of Cell-based CaRdiac stUdiEs: ACCRUE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Heart Disease
Keywords: meta-analysis
stem cell
cardiac
remodeling
ACCRUE
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Nantes University Hospital
name: Oslo University Hospital
name: Medical University of Silesia
name: Hannover Medical School
name: VZW Cardiovascular Research Center Aalst
name: Cedars-Sinai Medical Center
name: Johann Wolfgang Goethe University Hospital
name: University of Ulm
name: Military Medical Academy, Belgrade, Serbia
name: Novosibirsk Scientific Research Institute for Circulatory Pathology
name: Rigshospitalet, Denmark
name: Asklepios Kliniken Hamburg GmbH
name: Leiden University Medical Center
name: University of Debrecen
name: University of Targu Mures, Romania
name: University Clinic for Cardiology, Skopje, Republic of Macedonia
name: State Health Center, Hungary
name: Karolinska Institutet
name: University of Zurich
name: University of Oulu
name: Odense University Hospital
name: Minneapolis Heart Institute
name: The University of Texas Health Science Center, Houston
name: Klinik Hirslanden, Zurich
name: University Hospital, Toulouse
name: Heinrich-Heine University, Duesseldorf
First posted: 2010-04-05
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with cell-based cardiac therapy at one of the participating centers

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* none

Primary outcomes:
measure: Freedom from occurrence of major adverse cardiac and cerebrovascular events (MACCE), including all-cause death, re-infarction, revascularization and stroke
timeFrame: 12 months
Secondary outcomes:
measure: Hard clinical end point
timeFrame: 12 months
measure: Changes in end-diastolic volume
timeFrame: 12 months
measure: Changes in end-systolic volume
timeFrame: 12 months
measure: Changes in ejection fraction
timeFrame: 12 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Mariann Gyongyosi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.