This trial is active, not recruiting.

Conditions cardiovascular diseases, pulmonary embolism, venous thrombosis
Sponsor University of Minnesota - Clinical and Translational Science Institute
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date February 1998
End date December 2006
Trial size 21680 participants
Trial identifier NCT00005504, 5022, R01HL059367


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Venous thrombosis and pulmonary embolism
time frame: Yearly Follow up

Eligibility Criteria

Male or female participants from 45 years up to 100 years old.

No eligibility criteria

Additional Information

Official title Longitudinal Investigation of Thromboembolism Etiology
Principal investigator Aaron Folsom, MD, MPH
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 (e.g., plasminogen activator inhibitor-1) and related genetic variants, markers of thrombin activation, and other potentially important biochemical or related genetic factors (e.g., 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Minnesota - Clinical and Translational Science Institute.