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

NCT ID: NCT00395265

Last Updated: 2012-01-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2211 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2011-12-31

Brief 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.

Detailed 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.

Conditions

Venous Thrombosis; Venous Insufficiency

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Participated in the San Diego Population Study

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: collaborator

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

Mary Cushman

Professor of Medicine and Pathology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary Cushman, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Locations

University of Vermont College of Medicine

Burlington, Vermont, United States

Countries

United States

References

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. doi: 10.1093/aje/kwg166.

Reference Type: BACKGROUND

PMID: 12936900 (View on PubMed)

Other Identifiers

R01HL083926

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HL083926

Identifier Type: -

Identifier Source: secondary_id

1342

Identifier Type: -

Identifier Source: org_study_id