Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041457
Status:
COMPLETED
Last Update Posted:
2015-08-07
First Post:
2002-07-08
Brief Title:
Epidemiology of Venous Thromboembolism
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 77118 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 29071 US male physicians of whom 22071 have been followed since the initiation of the first trial in 1982 the Womens Health Study including 39876 female health professionals who will have an average of 10 years of follow-up and the Womens Antioxidant Cardiovascular Study including 8171 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 1000 incident cases of VTE including 750 with blood samples
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 77118 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 29071 US male physicians of whom 22071 have been followed since the initiation of the first trial in 1982 the Womens Health Study including 39876 female health professionals who will have an average of 10 years of follow-up and the Womens Antioxidant Cardiovascular Study including 8171 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 1000 incident cases of VTE including 750 with blood samples
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: