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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

N/A


Related Conditions & MeSH terms


NCT number NCT00005142
Study type Observational
Source National Heart, Lung, and Blood Institute (NHLBI)
Contact
Status Completed
Phase N/A
Start date July 1978
Completion date March 1990

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