Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005392
Status:
COMPLETED
Last Update Posted:
2016-02-29
First Post:
2000-05-25
Brief Title:
Epidemiology of Venous Disease
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 2408 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
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 2408 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL053487 | NIH | None | httpsreporternihgovquickSearchR01HL053487 |