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Home > "E" Clinical Trials Conditions > Epidemiology of Venous Thromboembolism  Epidemiology of Venous Thromboembolism
Epidemiology of Venous Thromboembolism
For Condition: Peripheral Vascular Diseases,Cardiovascular Diseases,Thromboembolism
Status: No longer recruiting
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To evaluate potentially modifiable lifestyle predictors of venous thromboembolism and their joint associations with biochemical and genetic determinants.
Details: BACKGROUND: Venous thromboembolism is a common condition with considerable morbidity and mortality. The disorder has diverse causes including trauma, stasis, drugs, cancer, and genetic factors that contribute to enhanced clotting and coagulation. The study uses existing large-scale population studies to unravel factors responsible for and contributing to venous thromboembolism. DESIGN NARRATIVE: The study design is a prospective cohort study of 77,118 persons based on pooling information from four large randomized trials of US health professionals that have collected detailed risk factor information and have used common strategies to prospectively identify and validate cases of venous thromboembolism (VTE). These trials are: Physicians' Health Studies I & II including 29,071 US male physicians, of whom 22,071 have been followed since the initiation of the first trial in 1982; the Women's Health Study including 39,876 female health professionals who will have an average of 10 years of follow-up; and the Women's Antioxidant Cardiovascular Study including 8,171 female health professionals with prevalent cardiovascular disease or at high risk of cardiovascular disease who will have an average of 8 years of follow-up. Archived blood samples were collected from approximately 75 percent of participants at baseline and will be used to assess biochemical and genetic markers of risk including factor V Leiden, the G20210A mutation in the prothrombin gene, hyperhomocysteinemia, and anticardiolipin antibodies. The study will assess the joint association with risk of these markers and potentially modifiable factors including body mass index, hormone replacement therapy, physical activity, and aspirin use. The study population will include over 1,000 incident cases of VTE, including 750 with blood samples.
Eligibility:
Study Type: Observational, Natural History, Longitudinal, Defined Population
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: No human subjects are involved. Collected data are used.
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertGlynn, , Brigham & Women's Hospital
Additional Information:
Study ID Numbers: 1183;
Study Start Date: July 2002
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00041457
Other Cardiovascular Diseases Studies:
1. Mechanisms of Low Levels of Apolipoprotein B
2. Epidemiology of Coronary Heart Disease in Men Aged 40 and Over
3. Chronic Stress as a Risk Factor in the Etiology of Coronary Heart Disease
4. Apolipoprotein A-I Gene Polymorphism and Atherosclerosis
5. Studies of Left Ventricular Dysfunction (SOLVD)
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Epidemiology of Venous Thromboembolism
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