- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00071565
Familial Intracranial Aneurysm Study II
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Intracranial aneurysms are "blisters" which form within the arteries at the base of the brain. A rupture of an aneurysm may lead to subarachnoid hemorrhage (SAH). The mortality rates of patients suffering from a SAH is 40 to 44 percent , with many survivors enduring major disability. Most of the deaths from SAH are due to rapid and massive brain injury from the initial bleeding, which is not correctable by medical and surgical intervention. Thus, prevention of aneurysm formation is of paramount importance.
Scientific evidence suggests that a genetic component plays an important role in the development of intracranial aneurysms, however the specific genes have not been identified. The Familial Intracranial Aneurysm Study is a collaborative research effort of neurologists and neurosurgeons throughout the United States, Canada, Australia and New Zealand to identify possible genes that may increase the risk of stroke, and particularly, the development of aneurysms in the blood vessels of the brain. This study will involve 475 families with multiple affected family members, and will also determine the effect of environmental factors such as cigarette smoking and high blood pressure on the expression of the genes.A group of physicians from throughout North America, Australia and New Zealand have formed a collaborative effect to identify genes that may be important in the development of aneurysms in the blood vessels of the brain. This study of affected individuals and families, known as the Familial Intracranial Aneurysm (FIA) study, is sponsored by the National Institutes of Health and has involved over 475 families.
FIA II will involve an additional 200 families plus 1800 subjects with an Intracranial Aneurysm but no family history. These families and individuals will be used to replicate the findings of FIA I. FIA II will take place in North America only.
To be eligible to participate in this study, families must have two or more affected pairs of siblings (brothers/sisters) or 3 or more family members affected with intracranial aneurysms. Subjects can participate if they do not have an eligible family history, but do have a confirmed intracranial aneurysm.
Participants will be asked to complete a family history questionnaire (if they have a family history) and a medical history questionnaire. They will also have their blood pressure measured and will give a small sample of blood. In addition, medical records will be requested to confirm the diagnosis of intracranial aneurysms. There will be no monetary compensation for participation.
The identification of susceptibility genes, along with a better understanding of environmental interactions such as cigarette smoking, may result in preventing the development of intracranial aneurysms and/or intracranial aneurysm ruptures in people who are at risk for this condition.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- University of Alabama
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California
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San Francisco, California, Estados Unidos, 94143-0114
- University of California,
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Florida
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Gainesville, Florida, Estados Unidos, 32610-0265
- University of Florida
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Indianapolis Neurosurgical Group
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Maryland
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Baltimore, Maryland, Estados Unidos, 21287
- Johns Hopkins University School of Medicine
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Baltimore, Maryland, Estados Unidos, 21201-1595
- University of Maryland
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Brigham & Women's Hospital
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Boston, Massachusetts, Estados Unidos, 02114-2698
- Massachusetts General Hospital
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109-0489
- University of Michigan
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic
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Missouri
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St. Louis, Missouri, Estados Unidos, 63110
- Washington University
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New York
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New York, New York, Estados Unidos, 10032
- Columbia University,
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45267
- University of Cincinnati, Department of Neurology
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15212
- Allegheny General Hospital
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22903
- University of Virginia
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Washington
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Seattle, Washington, Estados Unidos, 98104
- University of Washington
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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:
- To be eligible to participate in this study, families must have two or more affected pairs of siblings (brothers/sisters) or 3 or more family members affected with intracerebral aneurysms.
Sporadic aneurysm subjects must have a confirmed aneurysm.
Exclusion:
- A history of polycystic kidney disease, Marfan's Syndrome, Ehlers Danlos Syndrome, or fibromuscular dysplasia.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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1
475 families with multiple affected family members (phase I) 200 families with multiple affected family members (phase II) 1800 subjects with sporadic intracranial aneurysms
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Joseph P. Broderick, M.D., University of Cincinnati
Publicaciones y enlaces útiles
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
- Procesos Patológicos
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades Arteriales Intracraneales
- Hemorragias intracraneales
- Hemorragia
- Aneurisma
- Hemorragia subaracnoidea
- Aneurisma intracraneal
Otros números de identificación del estudio
- R01NS039512 (Subvención/contrato del NIH de EE. UU.)
- R01NS039512-06A1 (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. .