Epidemiology of Venous Thromboembolism
Primary Purpose
Cardiovascular Diseases, Thromboembolism, Peripheral Vascular Diseases
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No human subjects are involved. Collected data are used.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Arm Label
Physicians' Health Study I
Physicians' Health Study II
Women's Health Study
Women's Antioxidant Cardiovascular Health Study
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00041457
First Posted
July 8, 2002
Last Updated
August 5, 2015
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00041457
Brief Title
Epidemiology of Venous Thromboembolism
Study Type
Observational
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Thromboembolism, Peripheral Vascular Diseases
7. Study Design
8. Arms, Groups, and Interventions
Arm Title
Physicians' Health Study I
Arm Title
Physicians' Health Study II
Arm Title
Women's Health Study
Arm Title
Women's Antioxidant Cardiovascular Health Study
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
No human subjects are involved. Collected data are used.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Glynn
Organizational Affiliation
Brigham and Women's Hospital
12. IPD Sharing Statement
Citations:
PubMed Identifier
12601075
Citation
Ridker PM, Goldhaber SZ, Danielson E, Rosenberg Y, Eby CS, Deitcher SR, Cushman M, Moll S, Kessler CM, Elliott CG, Paulson R, Wong T, Bauer KA, Schwartz BA, Miletich JP, Bounameaux H, Glynn RJ; PREVENT Investigators. Long-term, low-intensity warfarin therapy for the prevention of recurrent venous thromboembolism. N Engl J Med. 2003 Apr 10;348(15):1425-34. doi: 10.1056/NEJMoa035029. Epub 2003 Feb 24.
Results Reference
background
PubMed Identifier
16207808
Citation
Glynn RJ, Rosner B. Comparison of risk factors for the competing risks of coronary heart disease, stroke, and venous thromboembolism. Am J Epidemiol. 2005 Nov 15;162(10):975-82. doi: 10.1093/aje/kwi309. Epub 2005 Oct 5.
Results Reference
background
Learn more about this trial
Epidemiology of Venous Thromboembolism
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