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| Sponsors and Collaborators: |
National Heart, Lung, and Blood Institute (NHLBI) University of California, San Diego |
|---|---|
| Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00395265 |
Purpose
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 |
|---|
|
Venous Thrombosis Venous Insufficiency |
| Study Type: | Observational |
| Study Design: | Cohort, Retrospective |
| Official Title: | Association of Thrombophilia and Inflammation With Post-Thrombotic Syndrome |
| Estimated Enrollment: | 2211 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | March 2009 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 40 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
This study will examine previously collected data from participants in the San Diego Population Study.
Inclusion Criteria:
Contacts and Locations| United States, Vermont | |
| University of Vermont College of Medicine | |
| Burlington, Vermont, United States, 05401 | |
| Principal Investigator: | Mary Cushman, MD, MSc | University of Vermont |
More Information
| Responsible Party: | University of Vermont ( Mary Cushman, MD, MSc ) |
| Study ID Numbers: | 1342, HL083926 |
| Study First Received: | October 31, 2006 |
| Last Updated: | February 1, 2008 |
| ClinicalTrials.gov Identifier: | NCT00395265 |
| Health Authority: | United States: Federal Government |
|
Deep Vein Thrombosis Chronic Venous Insufficiency Post Thrombotic Syndrome Blood Coagulation Inflammation |
|
Obesity Peripheral Vascular Diseases Blood Coagulation Disorders Thrombophilia Vascular Diseases Postthrombotic Syndrome Hemostatic Disorders Thrombosis |
Inflammation Embolism and Thrombosis Embolism Phlebitis Venous Insufficiency Venous Thrombosis Postphlebitic Syndrome |
|
Disease Pathologic Processes Syndrome Cardiovascular Diseases |
