Monitoring Trends in Venous Thromboembolism

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT00063518
First received: June 30, 2003
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

To describe time trends in the epidemiology of venous thromboembolism.


Condition
Blood Coagulation Disorders
Venous Thromboembolism
Cardiovascular Diseases

Study Type: Observational
Official Title: Incidence Rates, Clinical Profile, and Outcomes of Patients With Venous Thromboembolism

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Study Start Date: April 2003
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Detailed Description:

BACKGROUND:

Venous thromboembolism (VTE) has been estimated to be the third most common cardiovascular disorder. Frequently cited estimates of the incidence of VTE, and its associated outcomes, are based on studies conducted more than a decade ago and only in hospitalized patients. Contemporary data on the magnitude of this disorder, clinical profile of patients affected, acute and long-term outcomes, and use of different treatment strategies are needed given recent advances in diagnostic and therapeutic modalities.

DESIGN NARRATIVE:

The goals of the study are to collect population based data describing trends over time in the epidemiology of VTE including its incidence, management, short and long-term recurrence rates, and mortality. The study will take place in residents of the Worcester, Massachusetts, metropolitan area, (2000 census = 477,800) and will examine changes over time in these and additional endpoints for patients with validated VTE in 1998, 2000 and 2002 with a minimum follow-up of three years. Complementing the community based surveillance of VTE, newly diagnosed cases of VTE occurring in members of the largest Health Maintenance Organization (HMO) in Central Massachusetts between 1998 and 2002 will be identified. This cohort is tracked by an outpatient computer database allowing for the systematic collection of additional data on treatment practices and outcomes occurring outside of the hospital setting. The project will build on the investigators' clinical and epidemiological experience and on data collection methodologies used in the Worcester Deep Vein Thrombosis (DVT) study (1985-1989) and the ongoing Worcester Heart Attack Study. The medical records of Worcester area residents diagnosed with VTE and related diagnostic rubrics will be reviewed and validated according to pre-established diagnostic criteria. Records for additional hospitalizations and death certificates will be reviewed to examine trends in long-term recurrence and survival rates through 2005. The results of this study will provide much needed current reformation about the epidemiology of VTE and provide important data on current diagnostic and therapeutic strategies used in these patients. Implementation of this registry will set the stage for systematic long-term surveillance of this medically important problem.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00063518

Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
Principal Investigator: Frederick Spencer University of Massachusetts, Worcester
  More Information

No publications provided

Responsible Party: University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00063518     History of Changes
Other Study ID Numbers: 10387, R01HL070283
Study First Received: June 30, 2003
Last Updated: September 9, 2013
Health Authority: United States: National Institutes of Health

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Cardiovascular Diseases
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Hematologic Diseases
Vascular Diseases
Hemorrhagic Disorders
Embolism and Thrombosis
Thrombosis

ClinicalTrials.gov processed this record on August 18, 2014