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Epidemiology of Venous Disease

Primary Purpose

Cardiovascular Diseases, Peripheral Vascular Diseases, Telangiectasis

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

29 Years - 91 Years (Adult, Older Adult)All SexesDoes 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
    NCT00005392
    Brief Title
    Epidemiology of Venous Disease
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    July 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1995 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    July 2000 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    To conduct several studies on the epidemiology of venous disease.
    Detailed Description
    BACKGROUND: Venous disease is commonplace, more prevalent in women, increases with age, and is a major cause of morbidity. Between 6 and 30 percent of all medical expenditures for cardiovascular disease are for venous disease. Despite these facts, the basic epidemiology of venous disease has received limited attention. Even the definition of peripheral venous disease varies widely, often confusing symptoms and signs with demonstrable pathophysiologic abnormalities. This study provided estimates of the extent of peripheral venous disease, contributed to more efficient diagnosis, allowed insight on how to prevent or ameliorate this condition through risk factor modification, and provided quantitative estimates of the daily burden this disease imposes on patients. DESIGN NARRATIVE: The overall, and age, sex, and ethnic-specific, prevalence of peripheral venous disease was determined in a stratified multiethnic random sample of 2,408 men and women aged 29 to 91 years. Three specific categories of venous disease were defined including: telangiectasias and flat reticular veins; superficial venous disease without deep valvular incompetence or obstruction; deep venous disease, with valvular incompetence or obstruction. Varicose veins were typically but not invariably present in the latter two categories. These three categories were diagnosed by an ordered non-invasive evaluation, including visual inspection, with photographic documentation of abnormal findings, and duplex color sonography to diagnose valvular incompetence and venous obstruction. An evaluation was made of the sensitivity, specificity, and predictive value of each of the traditional signs and symptoms of venous disease for each of the three categories of venous disease. Signs and symptoms evaluated included aching, itching, swelling and edema, heaviness, cramps, nocturnal restless legs, pigmentation, induration, ulcers, and the Trendelenburg test. Risk factors were evaluated for each of the above three categories-of venous disease. Risk factors assessed included age; sex; ethnicity; socioeconomic status; height; weight; obesity; exercise; blood pressure; standing versus sitting in daily activities; family history of venous disease; cigarette smoking; alcohol consumption; diet; constipation; constrictive clothing; aspirin use; use of selected other medications; history of hernia, flat feet, or other conditions associated with connective tissue laxity; parity; use of estrogens or progestins; age at menarche; age at menopause; and concomitant arterial disease. Finally, an evaluation was made of the degree of morbidity and interference with daily activities resulting from venous disease, using the Quality of Well Being (QWB) scale developed at University of California at San Diego. 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, Telangiectasis

    7. Study Design

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    29 Years
    Maximum Age & Unit of Time
    91 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Criqui
    Organizational Affiliation
    University of California, San Diego

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    11331848
    Citation
    Fronek A, Criqui MH, Denenberg J, Langer RD. Common femoral vein dimensions and hemodynamics including Valsalva response as a function of sex, age, and ethnicity in a population study. J Vasc Surg. 2001 May;33(5):1050-6. doi: 10.1067/mva.2001.113496.
    Results Reference
    background
    PubMed Identifier
    15983292
    Citation
    Langer RD, Ho E, Denenberg JO, Fronek A, Allison M, Criqui MH. Relationships between symptoms and venous disease: the San Diego population study. Arch Intern Med. 2005 Jun 27;165(12):1420-4. doi: 10.1001/archinte.165.12.1420.
    Results Reference
    background
    PubMed Identifier
    12936900
    Citation
    Criqui MH, Jamosmos M, Fronek A, Denenberg JO, Langer RD, Bergan J, Golomb BA. Chronic venous disease in an ethnically diverse population: the San Diego Population Study. Am J Epidemiol. 2003 Sep 1;158(5):448-56. doi: 10.1093/aje/kwg166.
    Results Reference
    background

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    Epidemiology of Venous Disease

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