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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00000480 |
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.
Condition | Intervention | Phase |
---|---|---|
Arrhythmia Cardiovascular Diseases Coronary Disease Death, Sudden, Cardiac Heart Diseases Myocardial Ischemia Tachycardia, Ventricular |
Procedure: electrophysiology Drug: anti-arrhythmia agents Device: defibrillators, implantable |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Study Start Date: | September 1991 |
Estimated Study Completion Date: | September 1997 |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Men and women patients with documented coronary artery disease, ejection fraction less than or equal to 40 percent, and nonsustained asymptomatic ventricular tachycardia.
Study ID Numbers: | 70 |
Study First Received: | October 27, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000480 |
Health Authority: | United States: Federal Government |
Arterial Occlusive Diseases Death Heart Diseases Myocardial Ischemia Tachycardia Vascular Diseases Heart Arrest Ischemia |
Arteriosclerosis Coronary Disease Death, Sudden Death, Sudden, Cardiac Tachycardia, Ventricular Coronary Artery Disease Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |