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dc.contributor.authorCheng, Alan
dc.contributor.authorDalal, Darshan
dc.contributor.authorButcher, Barbara
dc.contributor.authorNorgard, Sanaz
dc.contributor.authorZhang, Yiyi
dc.contributor.authorDickfeld, Timm
dc.contributor.authorEldadah, Zayd A
dc.contributor.authorEllenbogen, Kenneth A
dc.contributor.authorGuallar, Eliseo 
dc.contributor.authorTomaselli, Gordon F
dc.identifier.citationJ Am Heart Assoc. 2013; 2(1):e000083es_ES
dc.description.abstractBACKGROUND: Primary-prevention implantable cardioverter-defibrillators (ICDs) reduce total mortality in patients with severe left ventricular systolic function. However, only a minority of patients benefit from these devices. We designed the Prospective Observational Study of Implantable Cardioverter-Defibrillators (PROSE-ICD) to identify risk factors and enhance our understanding of the biological mechanisms that predispose to arrhythmic death in patients undergoing ICD implantation for primary prevention of sudden death. METHODS AND RESULTS: This is a multicenter prospective cohort study with a target enrollment of 1200 patients. The primary end point is ICD shocks for adjudicated ventricular tachyarrhythmias. The secondary end point is total mortality. All patients undergo a comprehensive evaluation including history and physical examination, signal-averaged electrocardiograms, and blood sampling for genomic, proteomic, and metabolomic analyses. Patients are evaluated every 6 months and after every known ICD shock for additional electrocardiographic and blood sampling. As of December 2011, a total of 1177 patients have been enrolled with more nonwhite and female patients compared to previous randomized trials. A total of 143 patients have reached the primary end point, whereas a total of 260 patients died over an average follow-up of 59 months. The PROSE-ICD study represents a real-world cohort of individuals with systolic heart failure receiving primary-prevention ICDs. CONCLUSIONS: Extensive electrophysiological and structural phenotyping as well as the availability of serial DNA and serum samples will be important resources for evaluating novel metrics for risk stratification and identifying patients at risk for arrhythmic sudden death. CLINICAL TRIAL REGISTRATION: URL: Unique Identifier: NCT00733590.es_ES
dc.description.sponsorshipThis work was supported in part by the Donald W. Reynolds Cardiovascular Foundation and NIH R01 HL091062 (to G.F.T.).es_ES
dc.publisherAmerican Heart Associationes_ES
dc.relation.isversionofPublisher's versiones_ES
dc.subject.meshAged es_ES
dc.subject.meshArrhythmias, Cardiaces_ES
dc.subject.meshBiomarkers es_ES
dc.subject.meshDeath, Sudden, Cardiac es_ES
dc.subject.meshElectric Countershock es_ES
dc.subject.meshElectrocardiography es_ES
dc.subject.meshFemale es_ES
dc.subject.meshHeart Failure es_ES
dc.subject.meshHumans es_ES
dc.subject.meshKaplan-Meier Estimate es_ES
dc.subject.meshMale es_ES
dc.subject.meshMiddle Aged es_ES
dc.subject.meshPhysical Examination es_ES
dc.subject.meshPredictive Value of Tests es_ES
dc.subject.meshPrimary Prevention es_ES
dc.subject.meshProportional Hazards Models es_ES
dc.subject.meshProspective Studies es_ES
dc.subject.meshRisk Assessment es_ES
dc.subject.meshRisk Factors es_ES
dc.subject.meshTime Factors es_ES
dc.subject.meshTreatment Outcome es_ES
dc.subject.meshUnited States es_ES
dc.subject.meshDefibrillators, Implantable es_ES
dc.subject.meshResearch Design es_ES
dc.titleProspective observational study of implantable cardioverter-defibrillators in primary prevention of sudden cardiac death: study design and cohort descriptiones_ES
dc.rights.licenseAttribution-NonCommercial-NoDerivatives 4.0 Internacional*
dc.contributor.funderDonald W. Reynolds Cardiovascular Foundationes_ES
dc.contributor.funderNational Institues of Health (United States)es_ES
dc.identifier.journalJournal of the American Heart Associationes_ES
dc.repisalud.orgCNICCNIC::Grupos de investigación::Antiguos CNICes_ES

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Attribution-NonCommercial-NoDerivatives 4.0 Internacional
This item is licensed under a: Attribution-NonCommercial-NoDerivatives 4.0 Internacional