Evaluating the Relationship Between Blood Clotting Disorders, Inflammation, and Obesity in Individuals With Venous Disorders and Post-Thrombotic Syndrome

Venous Thrombosis Clinical Trial

Official title:

Association of Thrombophilia and Inflammation With Post-Thrombotic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00395265
• Other study ID #: 1342
• Secondary ID: R01HL083926HL083
• Status: Completed
• Phase: N/A
• First received: October 31, 2006
• Last updated: January 26, 2012
• Start date: June 2006
• Est. completion date: December 2011

Study information

• Verified date: January 2012
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

Venous thrombosis is the development of a blood clot in a vein. Post-thrombotic syndrome (PTS) is a painful condition that can develop following a venous thrombosis in one of the deep veins of the leg. While PTS is mainly thought to occur because of damage to the vein, other factors may be responsible for the development of this condition. This study will analyze genetic and biologic samples from participants of a previous study to examine other possible causes of venous diseases and PTS.

Description:

The long-term effects of venous thrombosis, known collectively as PTS, include persistent swelling, pain, cramps, and numbness in the leg. These symptoms result from impaired return of blood through the veins of the lower leg to the heart. PTS is believed to occur as a result of direct damage to the valves and walls of the vein. There may be specific factors that make certain individuals more prone to PTS. Individuals who are obese, have a genetic predisposition to blood clotting disorders, or have high levels of inflammation biomarkers may have an increased risk of developing venous diseases. The purpose of this study is to investigate the possible link between these factors and the occurrence of chronic venous disease and PTS. The study's findings will be useful in developing new prevention and treatment strategies.

This study will examine previously collected data from participants in the San Diego Population Study, a study that gathered information on the prevalence of chronic venous disease in a multi-ethnic group of individuals. There will be no study visits specifically for this study. Researchers will examine stored genetic and biologic samples of 370 control participants and 370 participants with chronic venous disease. Specifically, levels of inflammation biomarkers, levels of obesity-related biomarkers, and genetic predispositions for blood clotting disorders will be studied.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2211
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 79 Years

Eligibility

Inclusion Criteria:

• Participated in the San Diego Population Study

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Inflammation
• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Thrombosis
• Venous Insufficiency
• Venous Thrombosis

Locations

Country	Name	City	State
United States	University of Vermont College of Medicine	Burlington	Vermont

Sponsors (3)

Lead Sponsor	Collaborator
University of Vermont	National Heart, Lung, and Blood Institute (NHLBI), University of California, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (1)

Criqui MH, Jamosmos M, Fronek A, Denenberg JO, Langer RD, Bergan J, Golomb BA. Chronic venous disease in an ethnically diverse population: the San Diego Population Study. Am J Epidemiol. 2003 Sep 1;158(5):448-56. — View Citation