Cardiovascular DiseasesNCT00005392
Epidemiology of Venous Disease
An observational study of Cardiovascular Diseases and Peripheral Vascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To conduct several studies on the epidemiology of venous disease. Read more about this study
- Who is it for?
- Ages 29 to 91 years
- Conditions the study is for
- Cardiovascular Diseases, Peripheral Vascular Diseases, Telangiectasis
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1995to Jul 2000
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 to 91 years
- All sexes
- No healthy volunteers
- Adult, Older adult
No eligibility criteria
About this study
To conduct several studies on the epidemiology of venous disease.
Read the 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.
- Medical subject headings
- Cardiovascular Diseases, Peripheral Vascular Diseases, Telangiectasis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startSep 1995
- Study completionJul 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Michael Criqui, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005392
- Sponsor's protocol ID
- 4298
- Other IDs
- R01HL053487
- Status last verified
- Jul 2005
- First submitted
- 25 May 2000
- Last updated
- 29 Feb 2016
- Results posted
- No
Publications
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.
PubMed 11331848Langer 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.
PubMed 15983292Criqui 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.
PubMed 12936900
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Venous Disease
- ClinicalTrials.gov ID
- NCT00005392
- Acronym / sponsor ID
- 4298
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1995
- Study completion
- Jul 2000 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 29 to 91 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2016.
- Background: PubMed 11331848Fronek 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.
- Background: PubMed 15983292Langer 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.
- Background: PubMed 12936900Criqui 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Criqui
University of California, San Diego
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Peripheral Vascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005392, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2016.