NCT00000540

Brief Summary

To test the hypothesis that implantable cardioverter defibrillator (ICD) therapy will improve survival in coronary heart disease patients at high risk of death, especially arrhythmic death.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Dec 1992

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1992

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1998

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

November 7, 2016

Status Verified

August 1, 2004

First QC Date

October 27, 1999

Last Update Submit

November 4, 2016

Conditions

ArrhythmiaCardiovascular DiseasesCoronary DiseaseDeath, Sudden, CardiacHeart DiseasesMyocardial InfarctionMyocardial IschemiaVentricular Arrhythmia

Interventions

defibrillators, implantableDEVICE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Men and women, up to age 80, with a left ventricular ejection fraction less than .36 and an abnormal signal averaged electrocardiogram.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (16)

  • Bigger JT.The CABG Patch Trial. In: Santini M, ed. Progress in Clinical Pacing,1994. Armonk, NY: Futura Media Services, Inc., 1995:809-827.

    BACKGROUND

  • The Coronary Artery Bypass Graft (CABG) Patch Trial. The CABG Patch Trial Investigators and Coordinators. Prog Cardiovasc Dis. 1993 Sep-Oct;36(2):97-114. No abstract available.

    PMID: 8367611BACKGROUND

  • Spotnitz HM, Herre JM, Baker LD Jr, Fitzgerald DM, Kron IL, Bigger JT Jr. Surgical aspects of a randomized trial of defibrillator implantation during coronary artery bypass surgery. The CABG Patch Trial. Circulation. 1996 Nov 1;94(9 Suppl):II248-53.

    PMID: 8901755BACKGROUND

  • Kron IL, Cope JT, Baker LD Jr, Spotnitz HM. The risks of reoperative coronary artery bypass in chronic ischemic cardiomyopathy: results of the CABG Patch Trial. Circulation. 1997 Nov 4;96(9 Suppl):II-21-5.

    PMID: 9386070BACKGROUND

  • Bigger JT Jr. Prophylactic use of implanted cardiac defibrillators in patients at high risk for ventricular arrhythmias after coronary-artery bypass graft surgery. Coronary Artery Bypass Graft (CABG) Patch Trial Investigators. N Engl J Med. 1997 Nov 27;337(22):1569-75. doi: 10.1056/NEJM199711273372201.

    PMID: 9371853BACKGROUND

  • Curtis AB, Cannom DS, Bigger JT Jr, DiMarco JP, Estes NA 3rd, Steinman RC, Parides MK. Baseline characteristics of patients in the coronary artery bypass graft (CABG) Patch Trial. Am Heart J. 1997 Nov;134(5 Pt 1):787-98. doi: 10.1016/s0002-8703(97)80001-4.

    PMID: 9398090BACKGROUND

  • Bigger JT Jr, Parides MK, Rolnitzky LM, Meier P, Levin B, Egan DA. Changes in sample size and length of follow-up to maintain power in the coronary artery bypass graft (CABG) patch trial. Control Clin Trials. 1998 Feb;19(1):1-14. doi: 10.1016/s0197-2456(97)00124-4.

    PMID: 9492965BACKGROUND

  • Cook JR, Flack JE, Gregory CA, Deaton DW, Rousou JA, Engelman RM. Influence of the preoperative signal-averaged electrocardiogram on left ventricular function after coronary artery bypass graft surgery in patients with left ventricular dysfunction. The CABG Patch Trial. Am J Cardiol. 1998 Aug 1;82(3):285-9. doi: 10.1016/s0002-9149(98)00335-x.

    PMID: 9708654BACKGROUND

  • Spotnitz HM, Herre JM, Raza ST, Hammon JW Jr, Baker LD Jr, Fitzgerald DM, Kron IL, Bigger JT Jr. Effect of implantable cardioverter-defibrillator implantation on surgical morbidity in the CABG Patch Trial. Surgical Investigators of the Coronary Artery Bypass Graft Patch Trial. Circulation. 1998 Nov 10;98(19 Suppl):II77-80.

    PMID: 9852885BACKGROUND

  • Curtis AB, Bigger JT Jr, DiMarco JP, Anderson JL. Epicardial cardioverter-defibrillators do not cause postoperative arrhythmias. The CABG Patch Trial Investigators. Coronary Artery Bypass Graft. Am J Cardiol. 1998 Nov 1;82(9):1114-7, A9. doi: 10.1016/s0002-9149(98)00564-5.

    PMID: 9817491BACKGROUND

  • Namerow PB, Firth BR, Heywood GM, Windle JR, Parides MK. Quality-of-life six months after CABG surgery in patients randomized to ICD versus no ICD therapy: findings from the CABG Patch Trial. Pacing Clin Electrophysiol. 1999 Sep;22(9):1305-13. doi: 10.1111/j.1540-8159.1999.tb00623.x.

    PMID: 10527011BACKGROUND

  • Olshansky B, Telfer EA, Curtis AB, Bigger JT Jr. Predictive value of preoperative left ventricular ejection fraction and functional class for mortality and morbidity after high-risk coronary artery bypass grafting. Am J Cardiol. 2000 Jun 15;85(12):1489-91; A7. doi: 10.1016/s0002-9149(00)00801-8. No abstract available.

    PMID: 10856399BACKGROUND

  • Flack JE 3rd, Cook JR, May SJ, Lemeshow S, Engelman RM, Rousou JA, Deaton DW. Does cardioplegia type affect outcome and survival in patients with advanced left ventricular dysfunction? Results from the CABG Patch Trial. Circulation. 2000 Nov 7;102(19 Suppl 3):III84-9. doi: 10.1161/01.cir.102.suppl_3.iii-84.

    PMID: 11082368BACKGROUND

  • Argenziano M, Spotnitz HM, Whang W, Bigger JT Jr, Parides M, Rose EA. Risk stratification for coronary bypass surgery in patients with left ventricular dysfunction: analysis of the coronary artery bypass grafting patch trial database. Circulation. 1999 Nov 9;100(19 Suppl):II119-24. doi: 10.1161/01.cir.100.suppl_2.ii-119.

    PMID: 10567289BACKGROUND

  • Whang W, Bigger JT Jr. Diabetes and outcomes of coronary artery bypass graft surgery in patients with severe left ventricular dysfunction: results from The CABG Patch Trial database. The CABG Patch Trial Investigators and Coordinators. J Am Coll Cardiol. 2000 Oct;36(4):1166-72. doi: 10.1016/s0735-1097(00)00823-8.

    PMID: 11028466BACKGROUND

  • Bigger JT Jr, Whang W, Rottman JN, Kleiger RE, Gottlieb CD, Namerow PB, Steinman RC, Estes NA 3rd. Mechanisms of death in the CABG Patch trial: a randomized trial of implantable cardiac defibrillator prophylaxis in patients at high risk of death after coronary artery bypass graft surgery. Circulation. 1999 Mar 23;99(11):1416-21. doi: 10.1161/01.cir.99.11.1416.

    PMID: 10086963BACKGROUND

MeSH Terms

Conditions

Arrhythmias, CardiacCardiovascular DiseasesCoronary DiseaseDeath, Sudden, CardiacHeart DiseasesMyocardial InfarctionMyocardial Ischemia

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesHeart ArrestDeath, SuddenDeathInfarctionIschemiaNecrosis

Intervention Hierarchy (Ancestors)

DefibrillatorsElectrodesElectrical Equipment and SuppliesEquipment and SuppliesElectrodes, ImplantedProstheses and Implants

Study Officials

  • John Bigger

    Columbia University

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

December 1, 1992

Study Completion

December 1, 1998

Last Updated

November 7, 2016

Record last verified: 2004-08