COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00395265
Recruitment Status : Completed
First Posted : November 2, 2006
Last Update Posted : January 31, 2012
National Heart, Lung, and Blood Institute (NHLBI)
University of California, San Diego
Information provided by (Responsible Party):
Mary Cushman, University of Vermont

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.

Condition or disease
Venous Thrombosis Venous Insufficiency

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 2211 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Association of Thrombophilia and Inflammation With Post-Thrombotic Syndrome
Study Start Date : June 2006
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   40 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study will examine previously collected data from participants in the San Diego Population Study.

Inclusion Criteria:

  • Participated in the San Diego Population 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 identifier (NCT number): NCT00395265

Layout table for location information
United States, Vermont
University of Vermont College of Medicine
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
University of Vermont
National Heart, Lung, and Blood Institute (NHLBI)
University of California, San Diego
Layout table for investigator information
Principal Investigator: Mary Cushman, MD, MSc University of Vermont

Layout table for additonal information
Responsible Party: Mary Cushman, Professor of Medicine and Pathology, University of Vermont Identifier: NCT00395265    
Other Study ID Numbers: 1342
R01HL083926 ( U.S. NIH Grant/Contract )
First Posted: November 2, 2006    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: January 2012
Keywords provided by Mary Cushman, University of Vermont:
Deep Vein Thrombosis
Chronic Venous Insufficiency
Post Thrombotic Syndrome
Blood Coagulation
Additional relevant MeSH terms:
Layout table for MeSH terms
Venous Thrombosis
Venous Insufficiency
Postthrombotic Syndrome
Postphlebitic Syndrome
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases