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Epidemiology of Venous Thromboembolism

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ClinicalTrials.gov Identifier: NCT00041457
Recruitment Status : Completed
First Posted : July 9, 2002
Last Update Posted : August 7, 2015
Sponsor:
Information provided by (Responsible Party):
Robert James Glynn, PhD, Brigham and Women's Hospital

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

Condition or disease
Cardiovascular Diseases Thromboembolism Peripheral Vascular Diseases

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.


Study Type : Observational
Study Start Date : July 2002
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Group/Cohort
Physicians' Health Study I
Physicians' Health Study II
Women's Health Study
Women's Antioxidant Cardiovascular Health Study




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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
No human subjects are involved. Collected data are used.

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 ClinicalTrials.gov identifier (NCT number): NCT00041457


Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
OverallOfficial: Robert Glynn Brigham and Women's Hospital

Publications:
Responsible Party: Robert James Glynn, PhD, Biostatistician; Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00041457     History of Changes
Other Study ID Numbers: 1183
First Posted: July 9, 2002    Key Record Dates
Last Update Posted: August 7, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Cardiovascular Diseases
Thromboembolism
Venous Thromboembolism
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Embolism and Thrombosis
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases