Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005504
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-18
First Post:
2000-05-25
Brief Title:
Epidemiology of Venous Thrombosis and Pulmonary Embolism
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Longitudinal Investigation of Thromboembolism Etiology
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
LITE
Brief Summary:
To investigate venous thromboembolism in two carefully conducted prospective epidemiologic studies of African American and white adults -- the Atherosclerosis Risk in Communities ARIC Study and the Cardiovascular Health Study CHS
Detailed Description:
BACKGROUND
Venous thromboembolism comprising deep venous thrombosis DVT and pulmonary embolism PE is a major contributor to morbidity and mortality in the United States Nevertheless no comprehensive prospective population-based epidemiologic studies have simultaneously examined lifestyle molecular and biochemical risk factors for this important disease
DESIGN NARRATIVE
Deep venous thrombosis and pulmonary embolism cases were identified and verified in order to estimate incident rates of hospitalized venous thromboembolism in the combined ARIC and CHS cohorts The association of venous thromboembolism was determined prospectively with demographic and lifestyle factors plasma lipids medical history and hemostatic components including fibrinogen platelet count factors VIIc and VIIIc using existing ARIC and CHS data A nested case control study was conducted using stored pre-diagnosis blood and DNA specimens to determine the prospective associations of venous thromboembolism with the following levels of procoagulant or anticoagulant factors and related genetic variants including factor V Leiden fibrinolytic factors eg plasminogen activator inhibitor-1 and related genetic variants markers of thrombin activation and other potentially important biochemical or related genetic factors eg homocysteine
The study was renewed in 2003 to extend event follow-up for four more years and to conduct longitudinal analyses of incidence and potential risk factors not fully explored such as diet frailty hormone replace therapy and obesity interactions It was renewed in 2008 to conduct a genome wide association study It was again renewed in 2013 and 2017
Venous thromboembolism comprising deep venous thrombosis DVT and pulmonary embolism PE is a major contributor to morbidity and mortality in the United States Nevertheless no comprehensive prospective population-based epidemiologic studies have simultaneously examined lifestyle molecular and biochemical risk factors for this important disease
DESIGN NARRATIVE
Deep venous thrombosis and pulmonary embolism cases were identified and verified in order to estimate incident rates of hospitalized venous thromboembolism in the combined ARIC and CHS cohorts The association of venous thromboembolism was determined prospectively with demographic and lifestyle factors plasma lipids medical history and hemostatic components including fibrinogen platelet count factors VIIc and VIIIc using existing ARIC and CHS data A nested case control study was conducted using stored pre-diagnosis blood and DNA specimens to determine the prospective associations of venous thromboembolism with the following levels of procoagulant or anticoagulant factors and related genetic variants including factor V Leiden fibrinolytic factors eg plasminogen activator inhibitor-1 and related genetic variants markers of thrombin activation and other potentially important biochemical or related genetic factors eg homocysteine
The study was renewed in 2003 to extend event follow-up for four more years and to conduct longitudinal analyses of incidence and potential risk factors not fully explored such as diet frailty hormone replace therapy and obesity interactions It was renewed in 2008 to conduct a genome wide association study It was again renewed in 2013 and 2017
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL059367 | NIH | None | httpsreporternihgovquickSearchR01HL059367 |