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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00005142 |
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.
Condition |
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Cardiovascular Diseases Peripheral Vascular Diseases Arterial Occlusive Diseases |
Study Type: | Observational |
Study Design: | Natural History |
Study Start Date: | July 1978 |
Estimated Study Completion Date: | March 1990 |
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.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
No eligibility criteria
Study ID Numbers: | 1013 |
Study First Received: | May 25, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00005142 History of Changes |
Health Authority: | United States: Federal Government |
Arterial Occlusive Diseases Peripheral Vascular Diseases Vascular Diseases |
Arterial Occlusive Diseases Peripheral Vascular Diseases Vascular Diseases Cardiovascular Diseases |