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Etiology and Prevalence of Peripheral Arterial Disease

Primary Purpose

Cardiovascular Diseases, Peripheral Vascular Diseases, Arterial Occlusive Diseases

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    February 26, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005142
    Brief Title
    Etiology and Prevalence of Peripheral Arterial Disease
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    June 2000
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1978 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    March 1990 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief 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.
    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. The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Peripheral Vascular Diseases, Arterial Occlusive Diseases

    7. Study Design

    10. Eligibility

    Sex
    Male
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    3156006
    Citation
    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. doi: 10.1161/01.cir.71.3.510.
    Results Reference
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    PubMed Identifier
    3156007
    Citation
    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. doi: 10.1161/01.cir.71.3.516.
    Results Reference
    background
    PubMed Identifier
    4048078
    Citation
    Baker LL, Criqui MH. High- and low-density lipoprotein cholesterol: correlates in an older population. Prev Med. 1985 Mar;14(2):155-64. doi: 10.1016/0091-7435(85)90030-1.
    Results Reference
    background
    PubMed Identifier
    4028377
    Citation
    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. doi: 10.1161/01.cir.72.4.768.
    Results Reference
    background
    PubMed Identifier
    3728443
    Citation
    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. doi: 10.1093/oxfordjournals.aje.a114385.
    Results Reference
    background
    PubMed Identifier
    3813976
    Citation
    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. doi: 10.1161/01.atv.7.1.66.
    Results Reference
    background
    PubMed Identifier
    3578366
    Citation
    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. doi: 10.1016/0002-9343(87)90159-8.
    Results Reference
    background
    PubMed Identifier
    2786328
    Citation
    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. doi: 10.1093/oxfordjournals.aje.a115233.
    Results Reference
    background
    PubMed Identifier
    1726213
    Citation
    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. doi: 10.2165/00003495-199100425-00005.
    Results Reference
    background
    PubMed Identifier
    1729621
    Citation
    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. doi: 10.1056/NEJM199202063260605.
    Results Reference
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    Etiology and Prevalence of Peripheral Arterial Disease

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