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Trial NCT00000480

Resource URI: http://static.linkedct.org/resource/trials/NCT00000480
PropertyValue
linkedct:brief_title Multicenter Unsustained Tachycardia Trial (MUSTT)
linkedct:condition <http://static.linkedct.org/resource/condition/1156>
linkedct:condition <http://static.linkedct.org/resource/condition/12840>
linkedct:condition <http://static.linkedct.org/resource/condition/2312>
linkedct:condition <http://static.linkedct.org/resource/condition/3388>
linkedct:condition <http://static.linkedct.org/resource/condition/3593>
linkedct:condition <http://static.linkedct.org/resource/condition/5702>
linkedct:condition <http://static.linkedct.org/resource/condition/8489>
linkedct:criteria Men and women patients with documented coronary artery disease, ejection fraction less than or equal to 40 percent, and nonsustained asymptomatic ventricular tachycardia.
linkedct:description BACKGROUND: Cardiac arrest (sudden cardiac death) occurs relatively frequently in asymptomatic patients who have had myocardial infarctions, have ejection fractions less than 40 percent, and non-sustained ventricular tachycardia. However, it is not possible to predict who will die suddenly or when cardiac arrest will occur. Current efforts to reduce sudden death in such long-term survivors of myocardial infarction or in patients with coronary disease have produced results that are not very encouraging. Such patients may feel quite well. They survived their myocardial infarction and may have slight or even moderate reduction of exercise ability, but by 'pacing' themselves, such patients can lead relatively normal lives. They may be aware of their arrhythmia because of short periods of palpitations which may only trouble them transiently. Consequently, this group of patients, many still in the prime of their lives, are at relatively high risk of dying suddenly. The multicenter trial may reveal the most effective treatment for such patients, the value of electrophysiologic studies in predicting who is most at risk of sudden cardiac death, and whether electrophysiologic studies can help select the best mode of treatment. The protocol for performing programmed stimulation and serial drug testing is designed to mirror those currently in use by many practicing electrophysiologists. DESIGN NARRATIVE: Randomized, non-blind. Patients were assigned to standard therapy or to an aggressive arm consisting of electrophysiologic-guided antiarrhythmic therapy. Patients in the aggressive arm whose ventricular tachycardia was suppressible or who were still inducible, but who were hemodynamically stable in ventricular tachycardia, were followed on drug therapy. Otherwise, patients in the aggressive arm received an implantable defibrillator. The primary endpoint was sudden cardiac death or cardiac arrest. Patients without inducible sustained ventricular tachycardia were followed in a registry. Recruitment ceased on October 31, 1996 after a recommendation from the DSMB.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 75 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date September 1997
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000480
rdfs:label Trial NCT00000480
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000480
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 70
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/32856>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000480>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/10761>
linkedct:reference <http://static.linkedct.org/resource/reference/10944>
linkedct:reference <http://static.linkedct.org/resource/reference/10945>
linkedct:reference <http://static.linkedct.org/resource/reference/11400>
linkedct:reference <http://static.linkedct.org/resource/reference/14030>
linkedct:reference <http://static.linkedct.org/resource/reference/17792>
linkedct:reference <http://static.linkedct.org/resource/reference/23260>
linkedct:reference <http://static.linkedct.org/resource/reference/4211>
linkedct:reference <http://static.linkedct.org/resource/reference/48022>
linkedct:reference <http://static.linkedct.org/resource/reference/49932>
linkedct:reference <http://static.linkedct.org/resource/reference/5938>
linkedct:reference <http://static.linkedct.org/resource/reference/600>
linkedct:reference <http://static.linkedct.org/resource/reference/6005>
linkedct:reference <http://static.linkedct.org/resource/reference/7477>
linkedct:reference <http://static.linkedct.org/resource/reference/9547>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date September 1991
linkedct:study_design Treatment, Randomized
linkedct:study_type Interventional
linkedct:summary To determine the value of electrophysiologic (EP)-guided antiarrhythmic therapy in coronary heart disease patients at increased risk for sudden death. The study included a controlled clinical trial and a registry.
rdf:type linkedct:trials
linkedct:verification_date August 2004