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

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ClinicalTrials.gov Identifier: NCT00508079
Recruitment Status : Completed
First Posted : July 27, 2007
Last Update Posted : July 12, 2013
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Dr. Michael H. Criqui, University of California, San Diego

Brief Summary:
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 or disease
Peripheral Vascular Diseases

Detailed Description:

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.

Study Type : Observational
Actual Enrollment : 1103 participants
Observational Model: Cohort
Official Title: Incidence and Progression of Peripheral Venous Disease
Study Start Date : July 2007
Primary Completion Date : January 2011
Study Completion Date : January 2011

Primary Outcome Measures :
  1. Incident Venous Disease [ Time Frame: Since previous visit (approximately 11 years) ]

Biospecimen Retention:   Samples With DNA
Whole blood, serum, plasma

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Previous participants from the San Diego Population Study

Inclusion Criteria:

  • Participated in the SDPS study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00508079

United States, California
University of California San Diego
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Michael H. Criqui, MD, MPH University of California, San Diego

Responsible Party: Dr. Michael H. Criqui, Distinguished Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00508079     History of Changes
Other Study ID Numbers: 1389
R01HL084229-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 27, 2007    Key Record Dates
Last Update Posted: July 12, 2013
Last Verified: July 2013

Keywords provided by Dr. Michael H. Criqui, University of California, San Diego:
Venous Disease
Varicose Veins
Chronic Venous Insufficiency

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Arterial Occlusive Diseases