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| Tracking Information | |||||
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| First Received Date ICMJE | July 8, 2002 | ||||
| Last Updated Date | January 18, 2008 | ||||
| Start Date ICMJE | July 2002 | ||||
| Primary Completion Date | June 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00041457 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Epidemiology of Venous Thromboembolism | ||||
| Official Title ICMJE | |||||
| Brief Summary | To evaluate potentially modifiable lifestyle predictors of venous thromboembolism and their joint associations with biochemical and genetic determinants. |
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| 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. |
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| Study Phase | N/A | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | |||||
| Condition ICMJE |
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| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | June 2006 | ||||
| Primary Completion Date | June 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | No human subjects are involved. Collected data are used. |
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00041457 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 1183 | ||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Verification Date | January 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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