Document Detail


Design and rationale of the Reduction of Infarct Expansion and Ventricular Remodeling with Erythropoietin after Large Myocardial Infarction (REVEAL) trial.
MedLine Citation:
PMID:  21095264     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Acute myocardial infarction (MI) remains a leading cause of death despite advances in pharmacologic and percutaneous therapies. Animal models of ischemia/reperfusion have demonstrated that single-dose erythropoietin may reduce infarct size, decrease apoptosis, and increase neovascularization, possibly through mobilization of endothelial progenitor cells.
STUDY DESIGN: REVEAL is a randomized, double-blind, placebo-controlled, multicenter trial evaluating the effects of epoetin α on infarct size and left ventricular remodeling in patients with large MIs. The trial comprises a dose-escalation safety phase and a single-dose efficacy phase using the highest acceptable epoetin α dose up to 60,000 IU. Up to 250 ST-segment elevation myocardial infarction patients undergoing primary or rescue percutaneous coronary intervention will be randomized to intravenous epoetin α or placebo within 4 hours of successful reperfusion. The primary study end point is infarct size expressed as a percentage of left ventricular mass, as measured by cardiac magnetic resonance imaging 2 to 6 days post study medication administration. Secondary end points will assess changes in endothelial progenitor cell numbers and changes in indices of ventricular remodeling.
CONCLUSION: The REVEAL trial will evaluate the safety and efficacy of the highest tolerated single dose of epoetin α in patients who have undergone successful rescue or primary percutaneous coronary intervention for acute ST-segment elevation myocardial infarction.
Authors:
Chiara Melloni; Sunil V Rao; Thomas J Povsic; Laura Melton; Raymond J Kim; Rakhi Kilaru; Manesh R Patel; Mark Talan; Luigi Ferrucci; Dan L Longo; Edward G Lakatta; Samer S Najjar; Robert A Harrington
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Publication Detail:
Type:  Clinical Trial, Phase II; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Intramural    
Journal Detail:
Title:  American heart journal     Volume:  160     ISSN:  1097-6744     ISO Abbreviation:  Am. Heart J.     Publication Date:  2010 Nov 
Date Detail:
Created Date:  2010-11-24     Completed Date:  2011-01-18     Revised Date:  2013-07-03    
Medline Journal Info:
Nlm Unique ID:  0370465     Medline TA:  Am Heart J     Country:  United States    
Other Details:
Languages:  eng     Pagination:  795-803.e2     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2010 Mosby, Inc. All rights reserved.
Affiliation:
Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA. chiara.melloni@duke.edu
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00378352
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MeSH Terms
Descriptor/Qualifier:
Aged
Dose-Response Relationship, Drug
Double-Blind Method
Electrocardiography / drug effects*
Erythropoietin / administration & dosage*
Follow-Up Studies
Heart Ventricles / drug effects,  pathology*,  physiopathology
Hematinics / administration & dosage
Humans
Injections, Intravenous
Magnetic Resonance Imaging, Cine
Myocardial Infarction / diagnosis,  drug therapy*,  physiopathology
Recombinant Proteins
Recovery of Function / drug effects*
Treatment Outcome
United States
Ventricular Function, Left / drug effects*,  physiology
Ventricular Remodeling / drug effects,  physiology*
Chemical
Reg. No./Substance:
0/Hematinics; 0/Recombinant Proteins; 11096-26-7/Erythropoietin; 113427-24-0/epoetin alfa
Comments/Corrections

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


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