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
  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: Observational Model: Cohort
Official Title: Incidence and Progression of Peripheral Venous Disease

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Incident Venous Disease [ Time Frame: Since previous visit (approximately 11 years) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood, serum, plasma


Enrollment: 1103
Study Start Date: July 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Previous participants from the San Diego Population Study

Criteria

Inclusion Criteria:

  • Participated in the SDPS study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00508079

Locations
United States, California
University of California San Diego
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Michael H. Criqui, MD, MPH University of California, San Diego
  More Information

Additional Information:
No publications provided

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
Study First Received: July 25, 2007
Last Updated: July 10, 2013
Health Authority: United States: Federal Government

Keywords provided by University of California, San Diego:
Venous Disease
Varicose Veins
Chronic Venous Insufficiency
PAD

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

ClinicalTrials.gov processed this record on July 22, 2014