Cardiovascular Diseases Clinical Trial
To determine the prevalence of peripheral arterial disease in a defined population by non-invasive techniques; to evaluate the association of cardiovascular disease risk factors with peripheral vascular disease; to determine whether non-invasive tests of peripheral arterial disease can be utilized as markers for coronary heart disease; to determine the status of the microvasculature using conjunctival photographs and to compare the results with risk factors and the peripheral arterial disease testing results.
BACKGROUND:
Atherosclerosis is frequently generalized, affecting blood vessels in various parts of the
body. Previous studies had noted the strong association between peripheral arterial disease
and coronary heart disease and the similarity of risk factors, particularly diabetes and
cigarette smoking for both diseases. The natural history of peripheral arterial disease had
not been delineated because of the lack, until recently, of accurate and reliable
non-invasive testing.
DESIGN NARRATIVE:
All 624 subjects were initially studied under a Lipid Research Clinic protocol that involved
two evaluations, visit 1 and visit 2. At visit 2, half of the subjects were from a random
sample of the LRC visit 1 cohort and others were selected from the visit 1 cohort for
hyperlipidemia, defined as being at or above age- and sex-specific 90th percentiles for
cholesterol or 95th percentiles for triglycerides or taking lipid-lowering medications. At
visit 2, the subjects were characterized as to age; sex; drug, diet, alcohol and smoking
history; personal and family history of cardiovascular disease; Rose questionnaire; and
electrocardiogram and examination by a cardiologist. The subjects were given a traditional
manual examination for peripheral arterial disease and four non-invasive tests including
segmental blood pressure, flow velocity by Doppler ultrasound, postocclusive reactive
hyperemia, and pulse reappearance half-time. The subjects were categorized into large vessel
peripheral arterial disease, isolated small vessel peripheral arterial disease or normal
based on the results of non-invasive testing and followed for an average of four years.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
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