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

NCT ID: NCT00508079

Last Updated: 2013-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-07-31

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Peripheral Vascular Diseases

Study Design

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Observational Model Type

COHORT

Eligibility Criteria

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Inclusion Criteria

* Participated in the SDPS study
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Dr. Michael H. Criqui

Distinguished Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael H. Criqui, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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University of California San Diego

La Jolla, California, United States

Site Status

Countries

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United States

Other Identifiers

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R01HL084229-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1389

Identifier Type: -

Identifier Source: org_study_id

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