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Epidemiology of Venous Thrombosis and Pulmonary Embolism (LITE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00005504
First received: May 25, 2000
Last updated: May 23, 2017
Last verified: May 2017
May 25, 2000
May 23, 2017
February 1998
April 2030   (Final data collection date for primary outcome measure)
Venous thrombosis and pulmonary embolism [ Time Frame: Yearly Follow up ]
venous thrombosis and pulmonary embolism
Not Provided
Complete list of historical versions of study NCT00005504 on ClinicalTrials.gov Archive Site
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Epidemiology of Venous Thrombosis and Pulmonary Embolism
Longitudinal Investigation of Thromboembolism Etiology
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).

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:
DNA, serum, plasma
Probability Sample
ARIC and CHS cohorts
  • Cardiovascular Diseases
  • Pulmonary Embolism
  • Venous Thrombosis
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
21680
April 2030
April 2030   (Final data collection date for primary outcome measure)

Inclusion: in the ARIC or CHS cohorts already

Exclusion: not in the ARIC or CHS cohorts

Sexes Eligible for Study: All
45 Years to 100 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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NCT00005504
5022
R01HL059367 ( US NIH Grant/Contract Award Number )
No
Not Provided
No
Not Provided
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Aaron Folsom, MD, MPH University of Minnesota, MN
University of Minnesota - Clinical and Translational Science Institute
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP