Document Detail


COMPARE-AMI trial: comparison of intracoronary injection of CD133+ bone marrow stem cells to placebo in patients after acute myocardial infarction and left ventricular dysfunction: study rationale and design.
MedLine Citation:
PMID:  20560029     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Stem cell therapy has emerged as a promising approach to improve healing of the infarcted myocardium, to treat or prevent cardiac failure, and to restore lost cardiac function. Despite initial excitement, recent clinical trials using nonhomogenous human stem cells preparations showed variable results, raising concerns about the best cell type to transplant. Selected CD133(+) hematopoietic stem cells are promising candidate cells with great potential. COMPARE-acute myocardial infarction (AMI) study is a phase II, randomized, double-blind, placebo-controlled trial evaluating the safety and effectiveness of intracoronary CD133(+)-enriched hematopoietic bone marrow stem cells in patients with acute myocardial infarction and persistent left ventricular dysfunction. Patients who underwent successful percutaneous coronary intervention and present a persistent left ventricular ejection fraction <50% will be eligible to have bone marrow aspiration and randomized for intracoronary injection of selected CD 133(+) bone marrow cells vs placebo. The primary end point is a composite of a safety and efficacy end points evaluating the change at 4 months in the coronary atherosclerotic burden progression proximal and distal to the coronary stent in the infarct related artery; and the change in global left ventricular ejection fraction at 4 months relative to baseline as measured by magnetic resonance imaging. The secondary end point will be the occurrence of a major adverse cardiac event. To date, 14 patients were successfully randomized and treated without any protocol-related complication. COMPARE-AMI trial will help identify the effect of a selected population of the bone marrow stem cells on cardiac recovery of infarcted myocardium.
Authors:
Samer Mansour; Denis-Claude Roy; Vincent Bouchard; Ba Khoi Nguyen; Louis Mathieu Stevens; Francois Gobeil; Alain Rivard; Guy Leclerc; François Reeves; Nicolas Noiseux
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial     Date:  2009-11-12
Journal Detail:
Title:  Journal of cardiovascular translational research     Volume:  3     ISSN:  1937-5395     ISO Abbreviation:  J Cardiovasc Transl Res     Publication Date:  2010 Apr 
Date Detail:
Created Date:  2010-06-18     Completed Date:  2010-10-04     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101468585     Medline TA:  J Cardiovasc Transl Res     Country:  United States    
Other Details:
Languages:  eng     Pagination:  153-9     Citation Subset:  IM    
Affiliation:
Cardiology Department, Centre Hospitalier de l'Université de Montréal (CHUM), Hôtel Dieu, 3840, Rue Saint Urbain, Montreal, Québec, H2W 1T8, Canada. samer.mansour@sympatico.ca
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Angioplasty, Transluminal, Percutaneous Coronary
Antigens, CD / analysis*
Bone Marrow Cells / immunology*
Bone Marrow Transplantation*
Double-Blind Method
Female
Glycoproteins / analysis*
Hematopoietic Stem Cell Transplantation*
Hematopoietic Stem Cells / immunology*
Humans
Male
Middle Aged
Myocardial Infarction / pathology,  physiopathology,  surgery*
Myocardium / pathology
Peptides / analysis*
Recovery of Function
Research Design*
Stroke Volume
Time Factors
Treatment Outcome
Ventricular Dysfunction, Left / pathology,  physiopathology,  surgery*
Ventricular Function, Left
Chemical
Reg. No./Substance:
0/AC133 antigen; 0/Antigens, CD; 0/Glycoproteins; 0/Peptides

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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