Risk Factors for Venous Thromboembolism in the Community

Mayo Clinic

Status: Completed

Conditions: Thromboembolism; Cardiovascular Diseases

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00011180

864-98

R01HL066216 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

To evaluate the trends in the incidence of venous thromboembolism, to determine the risk factors for venous thromboembolism in patients with medical and surgical illness, and to evaluate the efficacy of the anticoagulant therapy in reducing venous thromboembolism.

Full description

BACKGROUND:

Venous thromboembolism (VTE) occurs frequently among patients hospitalized for major surgery or hospitalized for a medical illness primarily due to prolonged duration of immobilization. However, many patients undergo major surgery without any occurrence of VTE. Standard prophylactic therapy after surgery is heparin, which reduces the risk of VTE. However, heparin is associated with bleeding complications. Thus, it would be desirable to identify patients at high risk for VTE who might benefit the most from heparin therapy. An important focus of the study is to look at genetic factors which might play an important role in VTE incidence.

DESIGN NARRATIVE:

The study is a population based, retrospective case and case-control investigation of the genetic and environmental determinants of venous thromboembolism in the Rochester Minnesota Olmsted County population. The first five years of the study had three specific aims. The first specific aim was to update the 1966-1995 inception cohort to include Olmsted County residents with VTE during the five year period, 1996-2000. The second aim was to extend the analysis of risk factors for VTE by identifying two Olmsted County residents (controls) without VTE matched by age and gender to each definite or probable case within the 1996-2000 cohort, and to obtain plasma and genomic DNA from all cases and controls and perform a case-control study. The third specific aim was to evaluate the efficacy of anticoagulant therapy to prevent VTE recurrence.

The study was extended through March, 2009 to investigate trends in the incidence of venous thromboembolism, new risk factors including lipid-lowering, beta-blocker, and ACE-inhibitor therapies, and introduction of low molecular weight heparin (LMWH) therapy.

Enrollment: 385 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

No eligibility criteria

Trial design

385 participants in 2 patient groups

Incident Cohort with VTE

Description:

Olmsted County, Minnesota residents with with a first-lifetime deep vein thrombosis (DVT) or pulmonary embolism (PE) during the five year period, 1996-2000.

Controls without VTE

Description:

Two Olmsted County, Minnesota residents without venous thromboembolism (VTE) were matched by age and gender to each definite or probable case of VTE within the 1996-2000 cohort.