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