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Epidemiology of Venous Thrombosis and Pulmonary Embolism (LITE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00005504
Recruitment Status : Active, not recruiting
First Posted : May 26, 2000
Last Update Posted : October 29, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date May 25, 2000
First Posted Date May 26, 2000
Last Update Posted Date October 29, 2019
Actual Study Start Date February 1998
Estimated Primary Completion Date April 2030   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 23, 2017)
Venous thrombosis and pulmonary embolism [ Time Frame: Yearly Follow up ]
venous thrombosis and pulmonary embolism
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Epidemiology of Venous Thrombosis and Pulmonary Embolism
Official Title Longitudinal Investigation of Thromboembolism Etiology
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 (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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
DNA, serum, plasma
Sampling Method Probability Sample
Study Population ARIC and CHS cohorts
Condition
  • Cardiovascular Diseases
  • Pulmonary Embolism
  • Venous Thrombosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: May 14, 2008)
21680
Original Enrollment Not Provided
Estimated Study Completion Date April 2030
Estimated Primary Completion Date April 2030   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion: in the ARIC or CHS cohorts already

Exclusion: not in the ARIC or CHS cohorts

Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00005504
Other Study ID Numbers 9701M12240
R01HL059367 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Minnesota
Study Sponsor University of Minnesota
Collaborators National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Aaron Folsom, MD, MPH University of Minnesota
PRS Account University of Minnesota
Verification Date October 2019