Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005515
Status:
COMPLETED
Last Update Posted:
2016-02-10
First Post:
2000-05-25
Brief Title:
Mutations Hormone Therapy HRT and Venous Thromboembolism
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-07
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 assess the interaction between hormone replacement therapy and the prothrombotic mutations Factor V Leiden and the recently described prothrombin mutation 20210A on the incidence of venous thromboembolism VTE in a population-based case-control study conducted at Group Health Cooperative of Puget Sound GHC
Detailed Description:
BACKGROUND
Epidemiologic studies have identified Factor V Leiden as the most common cause of heritable thrombophilia a prothrombotic mutation associated with a 5 to 7-fold increase in the risk of venous thromboembolism VTE In pre-menopausal women the use of oral contraceptives is associated with a 4-fold increase in VTE risk and the joint effects of oral contraceptive use and Factor V Leiden carriership increase the VTE risk of by a factor of 35 Recently the results of several observational studies and randomized clinical trials suggest that in post-menopausal women the use of hormone replacement therapy is associated with a 3-fold increase in VTE risk Whether post-menopausal women with prothrombotic mutations experience a similar 20-fold increase in risk when they take post-menopausal hormones remains unknown
DESIGN NARRATIVE
In this case-control study post-menopausal women with a first episode of objectively confirmed venous thromboembolism and population-based controls were identified and recruited from the GHC enrollment files Controls were frequency matched to the cases on age and calendar-year Data collection included a review of ambulatory medical record and a telephone interview The GHC computerized pharmacy database was used to assess exposure to hormone replacement therapy A venous blood specimen was obtained from consenting subjects processed into aliquots of white cells plasma and red cells and stored at 70 degrees C prior to laboratory analysis DNA was extracted from white cells and molecular genotyping assays were conducted to assess carriership of prothrombotic mutations
Epidemiologic studies have identified Factor V Leiden as the most common cause of heritable thrombophilia a prothrombotic mutation associated with a 5 to 7-fold increase in the risk of venous thromboembolism VTE In pre-menopausal women the use of oral contraceptives is associated with a 4-fold increase in VTE risk and the joint effects of oral contraceptive use and Factor V Leiden carriership increase the VTE risk of by a factor of 35 Recently the results of several observational studies and randomized clinical trials suggest that in post-menopausal women the use of hormone replacement therapy is associated with a 3-fold increase in VTE risk Whether post-menopausal women with prothrombotic mutations experience a similar 20-fold increase in risk when they take post-menopausal hormones remains unknown
DESIGN NARRATIVE
In this case-control study post-menopausal women with a first episode of objectively confirmed venous thromboembolism and population-based controls were identified and recruited from the GHC enrollment files Controls were frequency matched to the cases on age and calendar-year Data collection included a review of ambulatory medical record and a telephone interview The GHC computerized pharmacy database was used to assess exposure to hormone replacement therapy A venous blood specimen was obtained from consenting subjects processed into aliquots of white cells plasma and red cells and stored at 70 degrees C prior to laboratory analysis DNA was extracted from white cells and molecular genotyping assays were conducted to assess carriership of prothrombotic mutations
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL060739 | NIH | None | httpsreporternihgovquickSearchR01HL060739 |