Document Detail


Design of the SHock Inhibition Evaluation with Azimilide (SHIELD) study: a novel method to assess antiarrhythmic drug effect in patients with an implantable cardioverter-defibrillator.
MedLine Citation:
PMID:  15642569     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
This report presents the rationale and study design details of the SHock Inhibition Evaluation with Azimilide study, which is recruiting 624 patients with implantable cardioverter-defibrillators (ICDs) who are at risk for life-threatening ventricular arrhythmia, randomized to azimilide 75 mg, azimilide 125 mg, or placebo and followed for 1 year. The objective of this study is to determine the effect of azimilide versus placebo on the symptomatic ventricular arrhythmia burden using a unique statistical analysis based on the unusual temporal distribution of symptomatic ICD therapies. The primary efficacy end points are time to all-cause shocks and time to all-cause shocks plus symptomatic ventricular arrhythmic events triggering antitachycardia pacing measured from randomization.
Authors:
Craig M Pratt; Paul Dorian; Hussein R Al-Khalidi; Jose M Brum; Martin Borggrefe; Daljit S Tatla; Johannes Brachmann; Robert J Myerburg; David S Cannom; Michael J Holroyde; Michael van der Laan; Stefan H Hohnloser;
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The American journal of cardiology     Volume:  95     ISSN:  0002-9149     ISO Abbreviation:  Am. J. Cardiol.     Publication Date:  2005 Jan 
Date Detail:
Created Date:  2005-01-11     Completed Date:  2005-02-17     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0207277     Medline TA:  Am J Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  274-6     Citation Subset:  AIM; IM    
Affiliation:
The Methodist DeBakey Heart Center and the Section of Cardiology, Department of Medicine, Baylor College of Medicine, 6565 Fannin Street, Houston, TX 77030, USA. cpratt@bcm.tmc.edu
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MeSH Terms
Descriptor/Qualifier:
Anti-Arrhythmia Agents / administration & dosage*
Defibrillators, Implantable*
Double-Blind Method
Drug Administration Schedule
Humans
Imidazolidines / administration & dosage*
Piperazines / administration & dosage*
Randomized Controlled Trials as Topic*
Research Design
Tachycardia, Ventricular / drug therapy,  therapy*
Treatment Outcome
Chemical
Reg. No./Substance:
0/Anti-Arrhythmia Agents; 0/Imidazolidines; 0/Piperazines; 149888-94-8/azimilide

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


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