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Multicenter Unsustained Tachycardia Trial (MUSTT)

Primary Purpose

Arrhythmia, Cardiovascular Diseases, Coronary Disease

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
electrophysiology
anti-arrhythmia agents
defibrillators, implantable
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arrhythmia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 27, 1999
    Last Updated
    January 13, 2017
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00000480
    Brief Title
    Multicenter Unsustained Tachycardia Trial (MUSTT)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2004
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1991 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 1996 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arrhythmia, Cardiovascular Diseases, Coronary Disease, Death, Sudden, Cardiac, Heart Diseases, Myocardial Ischemia, Tachycardia, Ventricular

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    electrophysiology
    Intervention Type
    Drug
    Intervention Name(s)
    anti-arrhythmia agents
    Intervention Type
    Device
    Intervention Name(s)
    defibrillators, implantable

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kerry Lee
    Organizational Affiliation
    Duke University

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    8234775
    Citation
    Buxton AE, Fisher JD, Josephson ME, Lee KL, Pryor DB, Prystowsky EN, Simson MB, DiCarlo L, Echt DS, Packer D, et al. Prevention of sudden death in patients with coronary artery disease: the Multicenter Unsustained Tachycardia Trial (MUSTT). Prog Cardiovasc Dis. 1993 Nov-Dec;36(3):215-26. doi: 10.1016/0033-0620(93)90015-6.
    Results Reference
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    PubMed Identifier
    8644986
    Citation
    Buxton AE, Lee KL, DiCarlo L, Echt DS, Fisher JD, Greer GS, Josephson ME, Packer D, Prystowsky EN, Talajic M. Nonsustained ventricular tachycardia in coronary artery disease: relation to inducible sustained ventricular tachycardia. MUSTT Investigators. Ann Intern Med. 1996 Jul 1;125(1):35-9. doi: 10.7326/0003-4819-125-1-199607010-00006.
    Results Reference
    background
    PubMed Identifier
    10199881
    Citation
    Buxton AE, Hafley GE, Lehmann MH, Gold M, O'Toole M, Tang A, Coromilas J, Hook B, Stamato NJ, Lee KL. Prediction of sustained ventricular tachycardia inducible by programmed stimulation in patients with coronary artery disease. Utility of clinical variables. Circulation. 1999 Apr 13;99(14):1843-50. doi: 10.1161/01.cir.99.14.1843.
    Results Reference
    background
    PubMed Identifier
    10590488
    Citation
    Klein HU, Reek S. The MUSTT study: evaluating testing and treatment. J Interv Card Electrophysiol. 2000 Jan;4 Suppl 1:45-50. doi: 10.1023/a:1009862028599.
    Results Reference
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    PubMed Identifier
    10874061
    Citation
    Buxton AE, Lee KL, DiCarlo L, Gold MR, Greer GS, Prystowsky EN, O'Toole MF, Tang A, Fisher JD, Coromilas J, Talajic M, Hafley G. Electrophysiologic testing to identify patients with coronary artery disease who are at risk for sudden death. Multicenter Unsustained Tachycardia Trial Investigators. N Engl J Med. 2000 Jun 29;342(26):1937-45. doi: 10.1056/NEJM200006293422602.
    Results Reference
    background
    PubMed Identifier
    10601507
    Citation
    Buxton AE, Lee KL, Fisher JD, Josephson ME, Prystowsky EN, Hafley G. A randomized study of the prevention of sudden death in patients with coronary artery disease. Multicenter Unsustained Tachycardia Trial Investigators. N Engl J Med. 1999 Dec 16;341(25):1882-90. doi: 10.1056/NEJM199912163412503. Erratum In: N Engl J Med 2000 Apr 27;342(17):1300.
    Results Reference
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    PubMed Identifier
    1146820
    Citation
    Gibson JT, Alexander VL, Newton DS. Influence on medication therapy of increased patient services by pharmacists in a pediatric hospital. Am J Hosp Pharm. 1975 May;32(5):495-500.
    Results Reference
    background
    PubMed Identifier
    1149972
    Citation
    Morgera T, Scardi S, Sponza A, Camerini F. [Self-measurement of blood pressure in hypertensive patients. A psychological study (author's transl)]. G Ital Cardiol. 1975;5(3):450-5. Italian.
    Results Reference
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    PubMed Identifier
    11499723
    Citation
    Mason JW. Mindfully mining MUSTT. Multicenter Unsustained Tachycardia Trial. J Am Coll Cardiol. 2001 Aug;38(2):352-4. doi: 10.1016/s0735-1097(01)01398-5. No abstract available.
    Results Reference
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    PubMed Identifier
    11583897
    Citation
    Pires LA, Lehmann MH, Buxton AE, Hafley GE, Lee KL; Multicenter Unsustained Tachycardia Trial Investigators. 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. 2001 Oct;38(4):1156-62. doi: 10.1016/s0735-1097(01)01482-6.
    Results Reference
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    PubMed Identifier
    11249889
    Citation
    Singh SN, Karasik P, Hafley GE, Pieper KS, Lee KL, Wyse DG, Buxton AE; MUSTT Investigators. Multicenter UnSustained Tachycardia Trial. 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 Tachycardia Trial. Am J Cardiol. 2001 Mar 15;87(6):716-20. doi: 10.1016/s0002-9149(00)01489-2.
    Results Reference
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    Citation
    Buxton A, Lee K, Fisher J, Josphson M, Prystowsky E, DiCarlo L, Echit D, Greer S, Paker D, Talajic , Pryor D, Hafley G, for the Multicenter UnSustained Tachycardia Trial Investigators . Characteristics of spontaneous nonsustained ventricular tachycardia in patients with coronary disease do not predict inducible sustained ventricular tachycardia. Pacing Clin Electrophysiol 1995;18:349.
    Results Reference
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    PubMed Identifier
    12105164
    Citation
    Lee KL, Hafley G, Fisher JD, Gold MR, Prystowsky EN, Talajic M, Josephson ME, Packer DL, Buxton AE; Multicenter Unsustained Tachycardia Trial Investigators. Effect of implantable defibrillators on arrhythmic events and mortality in the multicenter unsustained tachycardia trial. Circulation. 2002 Jul 9;106(2):233-8. doi: 10.1161/01.cir.0000021920.73149.c3.
    Results Reference
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    PubMed Identifier
    12821551
    Citation
    Russo AM, Hafley GE, Lee KL, Stamato NJ, Lehmann MH, Page RL, Kus T, Buxton AE; Multicenter UnSustained Tachycardia Trial Investigators. Racial differences in outcome in the Multicenter UnSustained Tachycardia Trial (MUSTT): a comparison of whites versus blacks. Circulation. 2003 Jul 8;108(1):67-72. doi: 10.1161/01.CIR.0000078640.59296.6F. Epub 2003 Jun 23.
    Results Reference
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    PubMed Identifier
    15289365
    Citation
    Zimetbaum PJ, Buxton AE, Batsford W, Fisher JD, Hafley GE, Lee KL, O'Toole MF, Page RL, Reynolds M, Josephson ME. Electrocardiographic predictors of arrhythmic death and total mortality in the multicenter unsustained tachycardia trial. Circulation. 2004 Aug 17;110(7):766-9. doi: 10.1161/01.CIR.0000139311.32278.32. Epub 2004 Aug 2.
    Results Reference
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