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Natural History of Peripheral Arterial Disease

Primary Purpose

Atherosclerosis, Coronary Disease, 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 Atherosclerosis

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
    NCT00005254
    Brief Title
    Natural History of Peripheral Arterial Disease
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    June 2000
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1990 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    March 1995 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    The Veterans Administration Patient Study examined the progression of peripheral arterial disease (PAD) in patients with large vessel PAD or isolated small vessel PAD. The Community Follow-up Study following subjects with and without PAD from a previous cohort to determine subsequent coronary heart disease and cardiovascular disease morbidity and mortality.
    Detailed Description
    BACKGROUND: Peripheral arterial disease is a common condition, particularly in the elderly, but is the least frequently studied and the least well understood of the major atherosclerotic diseases. DESIGN NARRATIVE: Veterans Administration Patient Study: The progression of PAD was followed in patients diagnosed at the San Diego VA Medical Center from July 1984 to June 1989. Four non-invasive tests used in the initial diagnosis were repeated after a five year interval. The tests included segmental blood pressure flow velocity by Doppler ultrasound, post-occlusive reactive hyperemia, and pulse reappearance time. Risk factors examined for related to PAD included cigarette smoking, alcohol consumption, lipids and lipoproteins, blood pressure, fasting plasma glucose, diabetes history, immunoglobulin E, and creatinine. The degree of concordance between PAD and carotid disease was evaluated using phonoangiography. Community Follow-up Study: The study was conducted in a cohort first examined for PAD in 1978-1981 and followed for morbidity and mortality. 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
    Atherosclerosis, Coronary Disease, Arterial Occlusive Diseases, Peripheral Vascular Diseases, Cardiovascular 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
    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
    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
    8067346
    Citation
    Feigelson HS, Criqui MH, Fronek A, Langer RD, Molgaard CA. Screening for peripheral arterial disease: the sensitivity, specificity, and predictive value of noninvasive tests in a defined population. Am J Epidemiol. 1994 Sep 15;140(6):526-34. doi: 10.1093/oxfordjournals.aje.a117279.
    Results Reference
    background
    PubMed Identifier
    10512592
    Citation
    Long TH, Criqui MH, Vasilevskis EE, Denenberg JO, Klauber MR, Fronek A. The correlation between the severity of peripheral arterial disease and carotid occlusive disease. Vasc Med. 1999;4(3):135-42. doi: 10.1177/1358836X9900400303.
    Results Reference
    background
    PubMed Identifier
    10355865
    Citation
    Bird CE, Criqui MH, Fronek A, Denenberg JO, Klauber MR, Langer RD. Quantitative and qualitative progression of peripheral arterial disease by non-invasive testing. Vasc Med. 1999;4(1):15-21. doi: 10.1177/1358836X9900400103.
    Results Reference
    background
    PubMed Identifier
    9546918
    Citation
    Criqui MH, Denenberg JO, Bird CE, Fronek A, Klauber MR, Langer RD. The correlation between symptoms and non-invasive test results in patients referred for peripheral arterial disease testing. Vasc Med. 1996;1(1):65-71. doi: 10.1177/1358863X9600100112.
    Results Reference
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    Natural History of Peripheral Arterial Disease

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