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Epidemiology of Venous Thromboembolism

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00041457
Enrollment
Unknown
Registered
2002-07-09
Start date
2002-07-31
Completion date
2006-06-30
Last updated
2015-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Peripheral Vascular Diseases, Thromboembolism

Brief summary

To evaluate potentially modifiable lifestyle predictors of venous thromboembolism and their joint associations with biochemical and genetic determinants.

Detailed description

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.

Interventions

None listed

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

No human subjects are involved. Collected data are used.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026