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Evaluating the Occurence of New and Progression of Existing Peripheral Venous Disease in Leg Veins

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dr. Michael H. Criqui, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00508079
First received: July 25, 2007
Last updated: July 10, 2013
Last verified: July 2013

July 25, 2007
July 10, 2013
July 2007
January 2011   (final data collection date for primary outcome measure)
Incident Venous Disease [ Time Frame: Since previous visit (approximately 11 years) ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00508079 on ClinicalTrials.gov Archive Site
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Evaluating the Occurence of New and Progression of Existing Peripheral Venous Disease in Leg Veins
Incidence and Progression of Peripheral Venous Disease

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.

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.

Observational
Observational Model: Cohort
Not Provided
Retention:   Samples With DNA
Description:

Whole blood, serum, plasma

Non-Probability Sample

Previous participants from the San Diego Population Study

Peripheral Vascular Diseases
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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
1103
January 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participated in the SDPS study
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00508079
1389, R01HL084229-01A1
No
Dr. Michael H. Criqui, University of California, San Diego
University of California, San Diego
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Michael H. Criqui, MD, MPH University of California, San Diego
University of California, San Diego
July 2013

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