Document Detail


Implementation of standardized assessment and reporting of myocardial infarction in contemporary randomized controlled trials: a systematic review.
MedLine Citation:
PMID:  23355654     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Myocardial infarction (MI) is a key endpoint in randomized controlled trials (RCTs), but heterogeneous definitions limit comparisons across RCTs or meta-analyses. The 2000 European Society of Cardiology/American College of Cardiology MI redefinition and the 2007 universal MI definition consensus documents made recommendations to address this issue. In cardiovascular randomized trials, we evaluated the impact of implementation of three key recommendations from these reports-troponin use to define MI; separate reporting of spontaneous and procedure-related MI; and infarct size reporting. We searched ClinicalTrials.gov and MEDLINE databases for cardiovascular RCTs with more than 500 patients in which enrolment began between September 2000 and July 2012 and that listed MI in the primary endpoint. We searched English-language publications with primary results or design papers. Of 3222 studies screened, 96 (3.0%) met our criteria. We extracted enrolment start date, number of patients and MI events, follow-up duration, and coronary revascularization rate. Data extraction quality was assessed by duplicated extractions. Of 96 RCTs, 80 had a primary results publication, comprising 608 091 patients and 43 621 endpoint MIs. Myocardial infarction represented 45.3% (95% confidence interval, 40.2-50.4) of events in the primary composite endpoint. Troponin defined MI in 57% (53/93) of trials with an MI definition available. Of these RCTs, three used troponin only if creatine kinase-MB was unavailable, six used troponin to define peri-procedural MI, seven specified the 99th percentile as the MI decision limit, and three reported spontaneous and procedure-related MI separately. None reported biomarker-based infarct size, but five reported MI as multiples of the assay upper limit of normal. Although MI is a major component of cardiovascular RCT primary endpoints, standardized MI reporting and implementation of consensus document recommendations for MI definition are limited. Developing appropriate strategies for uniform implementation is required.
Authors:
Sergio Leonardi; Paul W Armstrong; Phillip J Schulte; E Magnus Ohman; L Kristin Newby
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Publication Detail:
Type:  Journal Article; Research Support, N.I.H., Extramural; Review     Date:  2013-01-25
Journal Detail:
Title:  European heart journal     Volume:  34     ISSN:  1522-9645     ISO Abbreviation:  Eur. Heart J.     Publication Date:  2013 Mar 
Date Detail:
Created Date:  2013-03-22     Completed Date:  2013-09-13     Revised Date:  2014-03-26    
Medline Journal Info:
Nlm Unique ID:  8006263     Medline TA:  Eur Heart J     Country:  England    
Other Details:
Languages:  eng     Pagination:  894-902d     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Biological Markers / metabolism
Endpoint Determination
Guideline Adherence
Humans
Myocardial Infarction / diagnosis*
Myocardial Reperfusion / statistics & numerical data
Practice Guidelines as Topic
Randomized Controlled Trials as Topic
Terminology as Topic
Troponin / metabolism*
Grant Support
ID/Acronym/Agency:
T32HL079896/HL/NHLBI NIH HHS
Chemical
Reg. No./Substance:
0/Biological Markers; 0/Troponin
Comments/Corrections

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


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