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

This study has been completed.
Sponsor:
Collaborators:
University of California, San Diego
Information provided by (Responsible Party):
Mary Cushman, University of Vermont
ClinicalTrials.gov Identifier:
NCT00395265
First received: October 31, 2006
Last updated: January 26, 2012
Last verified: January 2012
  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: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Association of Thrombophilia and Inflammation With Post-Thrombotic Syndrome

Resource links provided by NLM:


Further study details as provided by University of Vermont:

Enrollment: 2211
Study Start Date: June 2006
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   40 Years to 79 Years
Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

  • Participated in the San Diego Population Study
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395265

Locations
United States, Vermont
University of Vermont College of Medicine
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
University of Vermont
University of California, San Diego
Investigators
Principal Investigator: Mary Cushman, MD, MSc University of Vermont
  More Information

Publications:
Responsible Party: Mary Cushman, Professor of Medicine and Pathology, University of Vermont
ClinicalTrials.gov Identifier: NCT00395265     History of Changes
Other Study ID Numbers: 1342, R01HL083926, HL083926
Study First Received: October 31, 2006
Last Updated: January 26, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Vermont:
Deep Vein Thrombosis
Chronic Venous Insufficiency
Post Thrombotic Syndrome
Blood Coagulation
Inflammation

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Inflammation
Postthrombotic Syndrome
Postphlebitic Syndrome
Thrombosis
Venous Insufficiency
Venous Thrombosis
Venous Thromboembolism
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Pathologic Processes
Embolism and Thrombosis
Phlebitis
Peripheral Vascular Diseases
Thromboembolism

ClinicalTrials.gov processed this record on July 22, 2014