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Etiology and Prevalence of Peripheral Arterial Disease
This study has been completed.
First Received: May 25, 2000   Last Updated: June 23, 2005   History of Changes
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00005142
  Purpose

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
Cardiovascular Diseases
Peripheral Vascular Diseases
Arterial Occlusive Diseases

MedlinePlus related topics: Peripheral Arterial Disease Vascular Diseases
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: July 1978
Estimated Study Completion Date: March 1990
Detailed 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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:
Criqui MH, Fronek A, Barrett-Connor E, Klauber MR, Gabriel S, Goodman D. The prevalence of peripheral arterial disease in a defined population. Circulation. 1985 Mar;71(3):510-5.
Criqui MH, Fronek A, Klauber MR, Barrett-Connor E, Gabriel S. The sensitivity, specificity, and predictive value of traditional clinical evaluation of peripheral arterial disease: results from noninvasive testing in a defined population. Circulation. 1985 Mar;71(3):516-22.
Baker LL, Criqui MH. High- and low-density lipoprotein cholesterol: correlates in an older population. Prev Med. 1985 Mar;14(2):155-64.
Criqui MH, Coughlin SS, Fronek A. Noninvasively diagnosed peripheral arterial disease as a predictor of mortality: results from a prospective study. Circulation. 1985 Oct;72(4):768-73.
Standeven M, Criqui MH, Klauber MR, Gabriel S, Barrett-Connor E. Correlates of change in postmenopausal estrogen use in a population-based study. Am J Epidemiol. 1986 Aug;124(2):268-74.
Barrett-Connor E, Criqui MH, Witztum JL, Philippi T, Zettner A. Population-based study of glycosylated hemoglobin, lipids, and lipoproteins in nondiabetic adults. Arteriosclerosis. 1987 Jan-Feb;7(1):66-70.
Criqui MH, Lee ER, Hamburger RN, Klauber MR, Coughlin SS. IgE and cardiovascular disease. Results from a population-based study. Am J Med. 1987 May;82(5):964-8.
Criqui MH, Browner D, Fronek A, Klauber MR, Coughlin SS, Barrett-Connor E, Gabriel S. Peripheral arterial disease in large vessels is epidemiologically distinct from small vessel disease. An analysis of risk factors. Am J Epidemiol. 1989 Jun;129(6):1110-9.
Criqui MH, Langer RD, Fronek A, Feigelson HS. Coronary disease and stroke in patients with large-vessel peripheral arterial disease. Drugs. 1991;42 Suppl 5:16-21.
Criqui MH, Langer RD, Fronek A, Feigelson HS, Klauber MR, McCann TJ, Browner D. Mortality over a period of 10 years in patients with peripheral arterial disease. N Engl J Med. 1992 Feb 6;326(6):381-6.

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

Study placed in the following topic categories:
Arterial Occlusive Diseases
Peripheral Vascular Diseases
Vascular Diseases

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009