Cardiovascular Diseases Clinical Trial
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.
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.
The study completion date listed in this record was obtained from the "End Date" entered in
the NIH Query View Report (QVR).
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