- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00063518
Monitoring Trends in Venous Thromboembolism
Incidence Rates, Clinical Profile, and Outcomes of Patients With Venous Thromboembolism
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Plan de estudios
¿Cómo está diseñado el estudio?
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Frederick Spencer, University of Massachusetts, Worcester
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 10387 (Otro identificador: CTEP)
- R01HL070283 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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