This application is a proposal to establish a statistical and data coordinating center for the multicenter study of electrophysiologic (EP)-guided antiarrhythmic therapy in patients with non-sustained ventricular tachycardia (VI). The study will enroll approximately 3,000 patients with chronic coronary artery disease, diminished left ventricular function, and asymptomatic non-sustained VT. After undergoing a baseline EP study, patients with inducible sustained at will be randomized to receive either no specific therapy, or antiarrhythmic therapy guided by serial electrophysiologic studies. AlI patients will be followed via clinic visits at 3 month intervals. The primary endpoint is sudden death or resuscitated cardiac arrest. Nine hundred patients will be randomized, with one-half allocated to each treatment arm. Patients eligible for randomization who choose not to enter the trial will he characterized and followed in a prospective registry. Patients who do not exhibit inducible sustained VT at the baseline EP study will also be enrolled in the registry and followed at similar intervals. As an integral part of this study, the coordinating center will perform the following major functions: (1) participate in all phases of planning and study design, (2) coordinate the preparation of data collection forms and procedures, (3) prepare and distribute a manual of operations, (4) provide training and guidance in data flection procedures, (5) coordinate the randomization of patients, (6) efficiently organize the flow and management of all patient data (baseline and follow-up), (7) establish and strictly adhere to high standards of quality control for data management, (8) perform on-site monitoring of completed data forms, (9) prepare regular status reports and summary information for study committees, (10) coordinate and perform appropriate statistical analyses of study data, and (11) participate in the preparation of study publications. Noteworthy features of this proposal include: a detailed assessment of sample size requirements; centralized (telephone) randomization of patients; assignment of antiarrhythmic drugs in a random order (in the EP-guided therapy arm); centralized double data entry; complete follow-up of all patients (including those not randomized); on-site review of study forms by trained nurse monitors; use of economical and efficient computer hardware and software; state-of-the-art methods of data analysis; and an experienced team of investigators. Through the services it provides, which extend across all aspects of study design, data collection, data management, and data analysis, this coordinating center will be a vital resource in the execution of this study. The results of the study are anticipated to provide important new clinical information and to greatly enhance the management and treatment of patients with non-sustained ventricular tachycardia.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01HL045726-05
Application #
2222442
Study Section
Clinical Trials Review Committee (CLTR)
Project Start
1991-09-30
Project End
1997-09-29
Budget Start
1995-09-30
Budget End
1996-09-29
Support Year
5
Fiscal Year
1995
Total Cost
Indirect Cost
Name
Duke University
Department
Public Health & Prev Medicine
Type
Schools of Medicine
DUNS #
071723621
City
Durham
State
NC
Country
United States
Zip Code
27705
Fisher, John D; Buxton, Alfred E; Lee, Kerry L et al. (2007) Designation and distribution of events in the Multicenter UnSustained Tachycardia Trial (MUSTT). Am J Cardiol 100:76-83
Buxton, Alfred E; Lee, Kerry L; Hafley, Gail E et al. (2007) Limitations of ejection fraction for prediction of sudden death risk in patients with coronary artery disease: lessons from the MUSTT study. J Am Coll Cardiol 50:1150-7
Buxton, Alfred E (2005) Should everyone with an ejection fraction less than or equal to 30% receive an implantable cardioverter-defibrillator? Not everyone with an ejection fraction < or = 30% should receive an implantable cardioverter-defibrillator. Circulation 111:2537-49; discussion 2537-49
Ellison, Kristin E; Hafley, Gail E; Hickey, Kathleen et al. (2002) Effect of beta-blocking therapy on outcome in the Multicenter UnSustained Tachycardia Trial (MUSTT). Circulation 106:2694-9
Pires, Luis A; Hafley, Gail E; Lee, Kerry L et al. (2002) Prognostic significance of nonsustained ventricular tachycardia identified postoperatively after coronary artery bypass surgery in patients with left ventricular dysfunction. J Cardiovasc Electrophysiol 13:757-63
Buxton, Alfred E; Lee, Kerry L; Hafley, Gail E et al. (2002) Relation of ejection fraction and inducible ventricular tachycardia to mode of death in patients with coronary artery disease: an analysis of patients enrolled in the multicenter unsustained tachycardia trial. Circulation 106:2466-72
Lee, Kerry L; Hafley, Gail; Fisher, John D et al. (2002) Effect of implantable defibrillators on arrhythmic events and mortality in the multicenter unsustained tachycardia trial. Circulation 106:233-8
Pires, L A; Lehmann, M H; Buxton, A E et al. (2001) Differences in inducibility and prognosis of in-hospital versus out-of-hospital identified nonsustained ventricular tachycardia in patients with coronary artery disease: clinical and trial design implications. J Am Coll Cardiol 38:1156-62
Singh, S N; Karasik, P; Hafley, G E et al. (2001) Electrophysiologic and clinical effects of angiotensin-converting enzyme inhibitors in patients with prior myocardial infarction, nonsustained ventricular tachycardia, and depressed left ventricular function. MUSTT Investigators. Multicenter UnSustained T Am J Cardiol 87:716-20
Gomes, J A; Cain, M E; Buxton, A E et al. (2001) Prediction of long-term outcomes by signal-averaged electrocardiography in patients with unsustained ventricular tachycardia, coronary artery disease, and left ventricular dysfunction. Circulation 104:436-41

Showing the most recent 10 out of 17 publications