Meta-Analysis of Cell-based CaRdiac stUdiEs: ACCRUE
ACCRUE
1 other identifier
observational
3,500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2007
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 30, 2010
CompletedFirst Posted
Study publicly available on registry
April 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJuly 13, 2021
July 1, 2021
13.1 years
March 30, 2010
July 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Hard clinical end point
12 months
Changes in end-diastolic volume
12 months
Changes in end-systolic volume
12 months
Changes in ejection fraction
12 months
Study Arms (2)
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
Interventions
Eligibility Criteria
Patients treated with cell-based cardiac therapy at one of the participating centers
You may qualify if:
- patient included in one of the registered cell-based cardiac therapy of the participating center
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical University of Viennalead
- Nantes University Hospitalcollaborator
- Oslo University Hospitalcollaborator
- Medical University of Silesiacollaborator
- Hannover Medical Schoolcollaborator
- VZW Cardiovascular Research Center Aalstcollaborator
- Cedars-Sinai Medical Centercollaborator
- Johann Wolfgang Goethe University Hospitalcollaborator
- University of Ulmcollaborator
- Military Medical Academy, Belgrade, Serbiacollaborator
- Novosibirsk Scientific Research Institute for Circulatory Pathologycollaborator
- Rigshospitalet, Denmarkcollaborator
- Asklepios Kliniken Hamburg GmbHcollaborator
- Leiden University Medical Centercollaborator
- University of Debrecencollaborator
- University of Targu Mures, Romaniacollaborator
- University Clinic for Cardiology, Skopje, Republic of Macedoniacollaborator
- State Health Center, Hungarycollaborator
- Karolinska Institutetcollaborator
- University of Zurichcollaborator
- University of Oulucollaborator
- Odense University Hospitalcollaborator
- Minneapolis Heart Institutecollaborator
- The University of Texas Health Science Center, Houstoncollaborator
- Klinik Hirslanden, Zurichcollaborator
- University Hospital, Toulousecollaborator
- Heinrich-Heine University, Duesseldorfcollaborator
Study Sites (1)
Medical University of Vienna
Vienna, 1090, Austria
Related Publications (1)
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.
PMID: 25700037DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mariann Gyongyosi, MD
Medical University of Vienna
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
March 30, 2010
First Posted
April 5, 2010
Study Start
November 1, 2007
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
July 13, 2021
Record last verified: 2021-07