LITE: Epidemiology of Venous Thrombosis and Pulmonary Embolism

Sponsor
University of Minnesota (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00005504
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
21,680
385.9

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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 (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 and 2017.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    21680 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Longitudinal Investigation of Thromboembolism Etiology
    Actual Study Start Date :
    Feb 1, 1998
    Anticipated Primary Completion Date :
    Apr 1, 2030
    Anticipated Study Completion Date :
    Apr 1, 2030

    Outcome Measures

    Primary Outcome Measures

    1. Venous thrombosis and pulmonary embolism [Yearly Follow up]

      venous thrombosis and pulmonary embolism

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion: in the ARIC or CHS cohorts already

    Exclusion: not in the ARIC or CHS cohorts

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Minnesota
    • National Heart, Lung, and Blood Institute (NHLBI)

    Investigators

    • Principal Investigator: Aaron Folsom, MD, MPH, University of Minnesota

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT00005504
    Other Study ID Numbers:
    • 9701M12240
    • R01HL059367
    First Posted:
    May 26, 2000
    Last Update Posted:
    Nov 12, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 12, 2021