CABG PATCH TRIAL--ADMINISTRATIVE AND CLINICAL CENTERS
Project Number5U01HL048159-02
Contact PI/Project LeaderBIGGER, JOHN THOMAS
Awardee OrganizationCOLUMBIA UNIV NEW YORK MORNINGSIDE
Description
Abstract Text
The CABG Patch Trial is a multicenter, randomized controlled clinical
trial 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, i.e., patients with
severe left ventricular dysfunction who also have a marker of arrhythmic
risk (positive signal averaged ECG). To address this question, patients
with coronary heart disease will be enrolled if they are having coronary
artery bypass graft surgery, are less than 80 years of age, have left
ventricular ejection fraction less than 0.36, and have a positive signal
averaged ECG. This group is similar to the patients who already have had
a sustained ventricular arrhythmia and therefore have an indication for
ICD treatment under current guidelines. Also, the group has a high
probability of experiencing death during followup. The treatment and
control groups are well matched for another important aspect of chronic
coronary heart disease - risk for ischemic events. Having both groups
revascularized at the beginning of the trial has the potential advantage
of sharpening the endpoint, i.e., a smaller proportion of all deaths are
expected to be ischemic, and a larger proportion are expected to be
arrhythmic, a pathophysiology that is addressed superbly by the treatment
under study. Enrolled patients will be randomized during surgery to
receive an ICD or not. We plan to randomize 800 patients, half to the
control group and half to the ICD group. Patients will be followed for
an average of three years after randomization. The CABG Patch Trial has
80%-85% power to detect a hypothesized 40% reduction in the 40-month
hazard rate for all-cause mortality in the ICD treated group. In
addition, The CABG Patch Trial will: document any morbidity of ICD
treatment; evaluate the effects of ICD therapy on quality of life; and
compare the health care costs of ICD treatment with those in the control
group. In the narrowest interpretation, the results will apply to high
risk coronary heart disease patients undergoing CABG surgery. Also, the
results should apply substantially to patients who satisfy the current
indications for ICD treatment and to some other high risk coronary heart
disease patients who have not yet had an arrhythmic event.
Public Health Relevance Statement
Data not available.
NIH Spending Category
No NIH Spending Category available.
Project Terms
antiarrhythmic agentarrhythmiaatherosclerosisclinical trialscoronary disorderdisease /disorder proneness /riskhealth care cost /financingheart disorder chemotherapyheart surgeryhuman morbidityhuman subjecthuman therapy evaluationimplantimplantable defibrillatorslongitudinal human studyquality of life
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