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| Sponsor: | National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00508079 |
Purpose
Peripheral venous disease occurs when a vein becomes damaged or blocked. It can occur almost anywhere in the body, but is most common in the arms and legs. This study will examine people who participated in a previous venous disease study to evaluate changes in leg veins and venous disease status over a period of 11 years.
| Condition |
|---|
|
Peripheral Vascular Diseases |
| Study Type: | Observational |
| Study Design: | Cohort |
| Official Title: | Incidence and Progression of Peripheral Venous Disease |
Whole blood, serum, plasma
| Estimated Enrollment: | 1200 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Peripheral venous disease is a general term for damage, defects, or blockage that occurs in the peripheral veins, which carry blood from the hands and feet back to the heart to receive oxygen. The most common cause of peripheral venous disease is a blood clot that blocks a vein. Varicose veins, which are swollen blood vessels near the surface of the skin, and chronic venous insufficiency, a condition in which blood in the leg veins does not drain properly, are two other common types of peripheral venous disease. From 1996 to 2000, the San Diego Population Study (SDPS) evaluated a group of individuals to gather information on the prevalence of venous disease. This current study will re-evaluate the SDPS participants to document changes that have occurred in their leg veins over the past 11 years, including any new venous disease and any progression of existing venous disease. Study researchers will also evaluate how venous disease relates to risk factors, symptoms, and quality of life issues.
This study will enroll people who participated in the SDPS study. Each participant will attend one study visit. Study staff will conduct a 1-hour interview with each participant to collect information on their medical history, disease-related symptoms, risk factors for venous disease, family health history, health habits, and quality of life. Blood collection will occur, participant's leg veins will be examined and photographed, and blood flow in the legs will be measured with an ultrasound.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Previous participants from the San Diego Population Study
Inclusion Criteria:
Contacts and Locations| United States, California | |
| University of California San Diego | |
| La Jolla, California, United States, 92093 | |
| Principal Investigator: | Michael H. Criqui, MD, MPH | University of California, San Diego |
More Information
| Responsible Party: | University of California, San Diego ( Michael H. Criqui, MD, MPH, Professor ) |
| Study ID Numbers: | 1389, R01 HL084229-01A1 |
| Study First Received: | July 25, 2007 |
| Last Updated: | July 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00508079 History of Changes |
| Health Authority: | United States: Federal Government |
|
Venous Disease Varicose Veins Chronic Venous Insufficiency PAD |
|
Peripheral Vascular Diseases Vascular Diseases Cardiovascular Diseases |