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Coronary Artery Bypass Graft (CABG) Patch Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000540
First Posted: October 28, 1999
Last Update Posted: November 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
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.

Condition Intervention Phase
Arrhythmia Cardiovascular Diseases Coronary Disease Death, Sudden, Cardiac Heart Diseases Myocardial Infarction Myocardial Ischemia Ventricular Arrhythmia Device: defibrillators, implantable Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: December 1992
Study Completion Date: December 1998
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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Men and women, up to age 80, with a left ventricular ejection fraction less than .36 and an abnormal signal averaged electrocardiogram.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000540


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: John Bigger Columbia University
  More Information

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.

ClinicalTrials.gov Identifier: NCT00000540     History of Changes
Other Study ID Numbers: 83
U01HL048120 ( U.S. NIH Grant/Contract )
U01HL048159 ( U.S. NIH Grant/Contract )
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: November 7, 2016
Last Verified: August 2004

Additional relevant MeSH terms:
Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Ischemia
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Death, Sudden
Death, Sudden, Cardiac
Pathologic Processes
Necrosis
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Death
Heart Arrest