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Multicenter Unsustained Tachycardia Trial (MUSTT)

This study has been completed.
Study NCT00000480.   Last updated on June 23, 2005.   Information provided by National Heart, Lung, and Blood Institute (NHLBI)

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Descriptive Information Fields
Brief Title  Multicenter Unsustained Tachycardia Trial (MUSTT)
Official Title 
Brief 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.

Detailed 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.

Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Arrhythmia
Cardiovascular Diseases
Coronary Disease
Death, Sudden, Cardiac
Heart Diseases
Myocardial Ischemia
Tachycardia, Ventricular
Intervention  Procedure: electrophysiology
Drug: anti-arrhythmia agents
Device: defibrillators, implantable
MEDLINE PMIDs 8234775,   8644986,   10199881,   10590488,   10874061,   10601507,   1146820,   1149972,   11499723,   11583897,   11249889,   12105164,   12821551,   15289365
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date  September 1991
Completion Date September 1997
Eligibility Criteria 

Men and women patients with documented coronary artery disease, ejection fraction less than or equal to 40 percent, and nonsustained asymptomatic ventricular tachycardia.

Gender Both
Ages 18 Years to 75 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries 
Administrative Information Fields
NCT ID  NCT00000480
Organization ID 70
Secondary IDs ††
Study Sponsor  National Heart, Lung, and Blood Institute (NHLBI)
Collaborators ††
Investigators 
Investigator:     Kerry Lee     Duke University    
Information Provided By National Heart, Lung, and Blood Institute (NHLBI)
Verification Date August 2004
First Received Date  October 27, 1999
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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