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NCT Number: NCT00005504

Epidemiology of Venous Thrombosis and Pulmonary Embolism

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Thrombosis Vascular Diseases Venous Thrombosis

Age range

45 year–100 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion: in the ARIC or CHS cohorts already

Exclusion: not in the ARIC or CHS cohorts

Treatment and study plan

Primary outcomes

  1. Venous thrombosis and pulmonary embolism

    Time frame: Yearly Follow up

    venous thrombosis and pulmonary embolism

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Longitudinal Investigation of Thromboembolism Etiology

Acronym: LITE

Important dates

Study start
1998
Primary completion
2030
Study completion
2030
First posted
May 26, 2000
Registry last updated
Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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