Measurement of Angiogenic Related Growth Factors in Urine and Blood From Patients With Pulmonary Vein Stenosis
Measurement of Angiogenic Related Growth Factors in Urine and Blood From Patients With Multivessel Pulmonary Vein Stenosis
Prospective, single center, descriptive study in 14 infants/children with multivessel pulmonary vein stenosis stratified for patients with or without underlying cardiac disease.
Group 1: Patients without additional structural heart disease and multivessel pulmonary vein stenosis.
Group 2: Patients with additional structural heart disease and multivessel pulmonary vein stenosis.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Patients identified at the time of presentation to their cardiologist will be asked to provide a urine sample for analysis. If blood is being drawn for other clinical tests, an extra vial of blood will be collected for measurement of bFGF, VEGF, angiopoietin 1&2 and ephrin. At the time of blood draws, approximately 4 cc's of heparin blood will be obtained and processed as detailed below. Blood and/or urine samples will be coordinated through the data manager and will be performed only when blood is being obtained for other reasons. Initially, blood samples will be sent to Lab Control, spun down, and the plasma isolated. Plasma will be coded, then frozen at -200C in the research lab. Urine samples will be aliquoted into vials and stored at -20 until further analysis.
All patient information will be kept confidential. Individual results will not be provided to patients. Identifiers to patient information will be maintained. No identifying patient information will be used in publications that might result from these studies. Information to be collected by the data manager will include age, sex, date of diagnosis and interventions.
The specific aim is to assess angiogenic growth factor concentrations in urine and blood from patients with both congenital and acquired multivessel pulmonary vein stenosis.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Children's Hospital Boston
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Boston, Massachusetts, Estados Unidos, 02115
- Dana Farber Cancer Institute
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Diagnosis can be based on clinical and radiographic grounds or at the time of biopsy or prior surgical procedures. The diagnosis must be consistent with multivessel pulmonary stenosis.
- There must be evidence of severe pulmonary vein stenosis in at least two pulmonary veins.
- Must give written informed consent according to institutional guidelines
Exclusion Criteria:
- Mechanism of pulmonary venous obstruction due to obvious anatomic cause, such as extrinsic compression
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Mark W Kieran, MD,PhD, Dana-Farber Cancer Institute
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CH X00-09-050
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