Epidemiology of Venous Disease

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005392
First received: May 25, 2000
Last updated: July 6, 2005
Last verified: July 2005

May 25, 2000
July 6, 2005
September 1995
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Complete list of historical versions of study NCT00005392 on ClinicalTrials.gov Archive Site
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Epidemiology of Venous Disease
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To conduct several studies on the epidemiology of venous disease.

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.

Observational
Observational Model: Natural History
Time Perspective: Cross-Sectional
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  • Cardiovascular Diseases
  • Peripheral Vascular Diseases
  • Telangiectasis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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July 2000
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No eligibility criteria

Both
29 Years to 91 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00005392
4298
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National Heart, Lung, and Blood Institute (NHLBI)
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Investigator: Michael Criqui University of California, San Diego
National Heart, Lung, and Blood Institute (NHLBI)
July 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP