Cardiovascular Diseases Clinical Trial
Official title:
Correlates of Angiographic Changes and Coronary Events: The Cholesterol-Lowering Atherosclerosis Study (CLAS)
To examine the appropriateness of angiographic and ultrasound endpoints as predictors of subsequent clinical coronary events. Follow-up data from the Cholesterol Lowering in Atherosclerosis Study (CLAS) were used.
BACKGROUND:
A multitude of coronary angiographic trials have been conducted using various endpoint
measures based on repeated coronary angiograms. Relative to coronary event trials,
angiographic trials require both a smaller sample size and reduced trial length. While such
trials have assumed that angiographic endpoints are valid surrogate measures for clinical
coronary events, this assumption has not been completely tested. Although several coronary
angiographic endpoints are available for trial outcomes, no single method has been uniformly
accepted as optimal. Because of this, the utility and validity of coronary angiographic
progression for predicting future clinical coronary events remains unsettled.
The recent advent of carotid ultrasonography to assess arterial intima-media thickness (IMT)
offers the exciting potential for a noninvasive measure of atherosclerosis. Because of its
noninvasiveness, carotid IMTallows the extension of anti-atherosclerotic trials to both
asymptomatic and frail subjects, for whom coronary angiography might be medically unethical.
Because there is currently only limited support for the association of carotid IMT with
clinical events or coronary atherosclerosis, the validity of carotid IMT as a potential
surrogate for either endpoint has not been established.
The Cholesterol Lowering Atherosclerosis Study (CLAS) was a coronary angiographic trial
testing the efficacy of colestipol-niacin therapy in 188 nonsmoking, 40-59 year old men with
previous coronary artery bypass graft surgery. Coronary artery atherosclerosis change was
evaluated both by human consensus panel and by quantitative coronary angiography (QCA). In
addition, B-mode ultrasounds of the common carotid artery was conducted every six months to
provide measures of carotid IMT. Since the competion of the two-year CLAS study, subjects
have been followed for up to 12 years. This long term follow-up of the CLAS cohort permits
examination of the appropriateness of angiographic and ultrasound arterial endpoints as
predictors of subsequent clinical coronary events. Angiographic and ultrasound (carotid IMT)
endpoints also allow for testing of the associations between these various serial measures
of atherosclerotic progression.
The results of these analyses will provide important information on the validity of these
measures, which are in current use as trial endpoints, as surrogates for clinical coronary
events.
DESIGN NARRATIVE:
The study used angiographic and ultrasound carotid intima medial thickness endpoints for
testing the associations between these various serial measures of atherosclerotic
progression and subsequent coronary heart disease.
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