Cardiovascular DiseasesLITENCT00005504
Epidemiology of Venous Thrombosis and Pulmonary Embolism
An observational study of Cardiovascular Diseases and Pulmonary Embolism, run by University of Minnesota.
Trial 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). Read more about this study
- Who is it for?
- Ages 45 to 100 years
- Conditions the study is for
- Cardiovascular Diseases, Pulmonary Embolism, Venous Thrombosis
- How many people
- 21,680 participants
- Where
- No sites listed yet
- Study dates
- Feb 1998to Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ARIC and CHS cohorts
Inclusion: in the ARIC or CHS cohorts already
Exclusion: not in the ARIC or CHS cohorts
About this study
Official title: 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).
Read the 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.
- Medical subject headings
- Cardiovascular Diseases, Pulmonary Embolism, Venous Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous thrombosis and pulmonary embolism
venous thrombosis and pulmonary embolism
Measured: Yearly Follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startFeb 1998
- Primary completionApr 2030 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21,680 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Weihong Tang, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005504
- Sponsor's protocol ID
- 9701M12240
- Other IDs
- R01HL059367
- Acronym
- LITE
- Status last verified
- Oct 2026
- First submitted
- 25 May 2000
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Folsom AR, Aleksic N, Wang L, Cushman M, Wu KK, White RH. Protein C, antithrombin, and venous thromboembolism incidence: a prospective population-based study. Arterioscler Thromb Vasc Biol. 2002 Jun 1;22(6):1018-22. doi: 10.1161/01.atv.0000017470.08363.ab.
PubMed 12067914Folsom AR, Cushman M, Tsai MY, Aleksic N, Heckbert SR, Boland LL, Tsai AW, Yanez ND, Rosamond WD. A prospective study of venous thromboembolism in relation to factor V Leiden and related factors. Blood. 2002 Apr 15;99(8):2720-5. doi: 10.1182/blood.v99.8.2720.
PubMed 11929758Folsom AR, Cushman M, Tsai MY, Heckbert SR, Aleksic N. Prospective study of the G20210A polymorphism in the prothrombin gene, plasma prothrombin concentration, and incidence of venous thromboembolism. Am J Hematol. 2002 Dec;71(4):285-90. doi: 10.1002/ajh.10229.
PubMed 12447958Folsom AR, Cushman M, Heckbert SR, Rosamond WD, Aleksic N. Prospective study of fibrinolytic markers and venous thromboembolism. J Clin Epidemiol. 2003 Jun;56(6):598-603. doi: 10.1016/s0895-4356(03)00052-0.
PubMed 12873656Aleksic N, Folsom AR, Cushman M, Heckbert SR, Tsai MY, Wu KK. Prospective study of the A455V polymorphism in the thrombomodulin gene, plasma thrombomodulin, and incidence of venous thromboembolism: the LITE Study. J Thromb Haemost. 2003 Jan;1(1):88-94. doi: 10.1046/j.1538-7836.2003.00029.x.
PubMed 12871544Tsai AW, Cushman M, Tsai MY, Heckbert SR, Rosamond WD, Aleksic N, Yanez ND, Psaty BM, Folsom AR. Serum homocysteine, thermolabile variant of methylene tetrahydrofolate reductase (MTHFR), and venous thromboembolism: Longitudinal Investigation of Thromboembolism Etiology (LITE). Am J Hematol. 2003 Mar;72(3):192-200. doi: 10.1002/ajh.10287.
PubMed 12605391Tsai AW, Cushman M, Rosamond WD, Heckbert SR, Tracy RP, Aleksic N, Folsom AR. Coagulation factors, inflammation markers, and venous thromboembolism: the longitudinal investigation of thromboembolism etiology (LITE). Am J Med. 2002 Dec 1;113(8):636-42. doi: 10.1016/s0002-9343(02)01345-1.
PubMed 12505113Cushman M, Tsai AW, White RH, Heckbert SR, Rosamond WD, Enright P, Folsom AR. Deep vein thrombosis and pulmonary embolism in two cohorts: the longitudinal investigation of thromboembolism etiology. Am J Med. 2004 Jul 1;117(1):19-25. doi: 10.1016/j.amjmed.2004.01.018.
PubMed 15210384Fashanu OE, Heckbert SR, Aguilar D, Jensen PN, Ballantyne CM, Basu S, Hoogeveen RC, deFilippi C, Cushman M, Folsom AR. Galectin-3 and Venous Thromboembolism Incidence: the Atherosclerosis Risk in Communities (ARIC) Study. Res Pract Thromb Haemost. 2017 Oct;1(2):223-230. doi: 10.1002/rth2.12038. Epub 2017 Sep 4.
PubMed 29152608Folsom AR, Tang W, George KM, Heckbert SR, MacLehose RF, Cushman M, Pankow JS. Prospective study of gamma' fibrinogen and incident venous thromboembolism: The Longitudinal Investigation of Thromboembolism Etiology (LITE). Thromb Res. 2016 Mar;139:44-9. doi: 10.1016/j.thromres.2016.01.008. Epub 2016 Jan 12.
PubMed 26916295Folsom AR, Tang W, Weng LC, Roetker NS, Cushman M, Basu S, Pankow JS. Replication of a genetic risk score for venous thromboembolism in whites but not in African Americans. J Thromb Haemost. 2016 Jan;14(1):83-8. doi: 10.1111/jth.13193. Epub 2015 Dec 29.
PubMed 26565658
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Investigation of Thromboembolism Etiology
- ClinicalTrials.gov ID
- NCT00005504
- Acronym / sponsor ID
- LITE / 9701M12240
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 21,680 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 1998 (actual)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ARIC and CHS cohorts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Venous thrombosis and pulmonary embolism
Time frame: Yearly Follow up
venous thrombosis and pulmonary embolism
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Background: PubMed 12067914Folsom AR, Aleksic N, Wang L, Cushman M, Wu KK, White RH. Protein C, antithrombin, and venous thromboembolism incidence: a prospective population-based study. Arterioscler Thromb Vasc Biol. 2002 Jun 1;22(6):1018-22. doi: 10.1161/01.atv.0000017470.08363.ab.
- Background: PubMed 11929758Folsom AR, Cushman M, Tsai MY, Aleksic N, Heckbert SR, Boland LL, Tsai AW, Yanez ND, Rosamond WD. A prospective study of venous thromboembolism in relation to factor V Leiden and related factors. Blood. 2002 Apr 15;99(8):2720-5. doi: 10.1182/blood.v99.8.2720.
- Background: PubMed 12447958Folsom AR, Cushman M, Tsai MY, Heckbert SR, Aleksic N. Prospective study of the G20210A polymorphism in the prothrombin gene, plasma prothrombin concentration, and incidence of venous thromboembolism. Am J Hematol. 2002 Dec;71(4):285-90. doi: 10.1002/ajh.10229.
- Background: PubMed 12873656Folsom AR, Cushman M, Heckbert SR, Rosamond WD, Aleksic N. Prospective study of fibrinolytic markers and venous thromboembolism. J Clin Epidemiol. 2003 Jun;56(6):598-603. doi: 10.1016/s0895-4356(03)00052-0.
- Background: PubMed 12871544Aleksic N, Folsom AR, Cushman M, Heckbert SR, Tsai MY, Wu KK. Prospective study of the A455V polymorphism in the thrombomodulin gene, plasma thrombomodulin, and incidence of venous thromboembolism: the LITE Study. J Thromb Haemost. 2003 Jan;1(1):88-94. doi: 10.1046/j.1538-7836.2003.00029.x.
- Background: PubMed 12605391Tsai AW, Cushman M, Tsai MY, Heckbert SR, Rosamond WD, Aleksic N, Yanez ND, Psaty BM, Folsom AR. Serum homocysteine, thermolabile variant of methylene tetrahydrofolate reductase (MTHFR), and venous thromboembolism: Longitudinal Investigation of Thromboembolism Etiology (LITE). Am J Hematol. 2003 Mar;72(3):192-200. doi: 10.1002/ajh.10287.
- Background: PubMed 12505113Tsai AW, Cushman M, Rosamond WD, Heckbert SR, Tracy RP, Aleksic N, Folsom AR. Coagulation factors, inflammation markers, and venous thromboembolism: the longitudinal investigation of thromboembolism etiology (LITE). Am J Med. 2002 Dec 1;113(8):636-42. doi: 10.1016/s0002-9343(02)01345-1.
- Background: PubMed 15210384Cushman M, Tsai AW, White RH, Heckbert SR, Rosamond WD, Enright P, Folsom AR. Deep vein thrombosis and pulmonary embolism in two cohorts: the longitudinal investigation of thromboembolism etiology. Am J Med. 2004 Jul 1;117(1):19-25. doi: 10.1016/j.amjmed.2004.01.018.
- Background: PubMed 29152608Fashanu OE, Heckbert SR, Aguilar D, Jensen PN, Ballantyne CM, Basu S, Hoogeveen RC, deFilippi C, Cushman M, Folsom AR. Galectin-3 and Venous Thromboembolism Incidence: the Atherosclerosis Risk in Communities (ARIC) Study. Res Pract Thromb Haemost. 2017 Oct;1(2):223-230. doi: 10.1002/rth2.12038. Epub 2017 Sep 4.
- Background: PubMed 26916295Folsom AR, Tang W, George KM, Heckbert SR, MacLehose RF, Cushman M, Pankow JS. Prospective study of gamma' fibrinogen and incident venous thromboembolism: The Longitudinal Investigation of Thromboembolism Etiology (LITE). Thromb Res. 2016 Mar;139:44-9. doi: 10.1016/j.thromres.2016.01.008. Epub 2016 Jan 12.
- Background: PubMed 26565658Folsom AR, Tang W, Weng LC, Roetker NS, Cushman M, Basu S, Pankow JS. Replication of a genetic risk score for venous thromboembolism in whites but not in African Americans. J Thromb Haemost. 2016 Jan;14(1):83-8. doi: 10.1111/jth.13193. Epub 2015 Dec 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weihong Tang, PhD principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Pulmonary Embolism, run by University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous thrombosis and pulmonary embolism (time frame: Yearly Follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005504, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.