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AzTrials

ArrhythmiaPhase 3NCT00000540

Coronary Artery Bypass Graft (CABG) Patch Trial

A Phase 3 study testing defibrillators, implantable in people with Arrhythmia and Cardiovascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
defibrillators, implantable
Type of treatment
Medical device
How many people
Not given
Where
No sites listed yet
Study dates
Dec 1992to Dec 1998
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Men and women, up to age 80, with a left ventricular ejection fraction less than .36 and an abnormal signal averaged electrocardiogram.

About this study

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.

Read the detailed description

BACKGROUND:

Management strategies are urgently needed for the problem of sudden cardiac death, the most common single, non-accidental cause of death in adults in North America. Many consider that the problem of sudden cardiac death has reached epidemic proportions. Contemporary prophylactic management of sudden cardiac death includes identification of high risk populations, based on underlying structural heart disease, degree of left ventricular dysfunction, and evidence of a ventricular arrhythmia propensity. Populations with the highest sudden death cardiac risk, notably those patients resuscitated from spontaneous episodes of sustained ventricular tachyarrhythmias, have been used as test populations for the development of effective prophylactic approaches. However, in such populations, ethical considerations have precluded the use of untreated control groups. Furthermore, such patients comprise only a small proportion of the total patient population that could benefit from an effective prophylactic strategy. The largest 'at-risk' group are those patients with coronary artery disease and depressed left ventricular function who have, but have not yet expressed, a ventricular tachyarrhythmia propensity. The major advantages of a controlled trial of prophylactic therapy in the latter population are evaluation of sudden death prophylaxis in the larger 'at-risk' population and the opportunity to do so with an untreated control group. The 'window of opportunity' for such comparisons has been closed in resuscitated patients for some time and is in danger of closing in the larger population. The total absence of controlled efficacy data for ICD use despite 30,000 implanted units of this expensive technology argues strongly for the timely acquisition of controlled data in the larger population before the therapy is embraced any further.

DESIGN NARRATIVE:

Randomized, non-blind. Patients were randomized during surgery for coronary artery bypass graft to receive ICD or not, and followed and censored at 42 months at 35 centers. The primary endpoint was all-cause mortality. The trial described morbidity of ICD treatment, evaluated the effect of ICD therapy on quality of life, and compared health care costs of ICD treatment to those in the control group. Anti-arrhythmic treatment of unsustained arrhythmia was prohibited; anti-arrhythmic drug use, when indicated, was documented; and aspirin was prescribed unless contraindications existed. Recruitment was extended through December 1995 in order to accrue 900 patients, instead of the original 800 projected. As of February 1996, 900 patients had been recruited. In April 1997, the DSMB recommended that the trial be stopped because there was sufficient evidence to conclude that there was no difference between the treatment and control groups. Follow-up was extended for two years beyond the original termination date.

The study completion date listed in this record was obtained from the "End Date" entered in the old format Protocol Registration and Results System (PRS).

Being tested
defibrillators, implantable
Medical subject headings
Arrhythmias, Cardiac, Cardiovascular Diseases, Coronary Disease, Death, Sudden, Cardiac, Heart Diseases, Myocardial Infarction, Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • defibrillators, implantableDevice

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 1999 (estimated)
  2. Study startDec 1992
  3. Study completionDec 1998

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000540
Sponsor's protocol ID
83
Other IDs
U01HL048120, U01HL048159
Status last verified
Aug 2004
First submitted
27 Oct 1999
Last updated
7 Nov 2016
Results posted
No

Publications

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

  • 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.

    PubMed 8367611

  • 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.

    PubMed 8901755

  • 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.

    PubMed 9386070

  • 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.

    PubMed 9371853

  • 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.

    PubMed 9398090

  • 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.

    PubMed 9492965

  • 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.

    PubMed 9708654

  • 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.

    PubMed 9852885

  • 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.

    PubMed 9817491

  • 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.

    PubMed 10527011

  • 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.

    PubMed 10856399

  • 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.

    PubMed 11082368

  • 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.

    PubMed 10567289

  • 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.

    PubMed 11028466

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing defibrillators, implantable in people with Arrhythmia and Cardiovascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00000540, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2016.

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