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Evaluation and Treatment of Patients Spinal Blood Vessel Abnormalities

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Qué se está recopilando

Recolección de datos

Quiénes están siendo reclutados

Arteriovenous Fistula

+ Arteriovenous Malformation
+ Spinal Cord Disease
A partir de 4 años
Cómo está diseñado el estudio

Other

Observacional
Inicio del estudio: junio de 1993

Resumen

Patrocinador PrincipalNational Institute of Neurological Disorders and Stroke (NINDS)
Última actualización: 2 de julio de 2017
Extraido de una base de datos validada por el gobierno.Reclamar como socio
Fecha de inicio: 2 de junio de 1993Fecha en la que se inscribió al primer participante.

Arteriovenous malformations (AVM) are abnormally formed blood vessels that can be located throughout the brain and spinal cord. Patients with abnormalities of the blood vessels located in and around the spinal cord can develop many neurological problems. Some problems include, weakness, pain, difficulty walking, paralysis, and even death. The treatment for these AVMs depends on their location, the type of malformation, the area of the spine involved, and the condition of the patient at the time of treatment. The treatment is aimed at stopping the neurologic problems from worsening and possibly correcting the existing problems. There are two commonly used treatments for AVMs, surgery and embolization (blocking off of blood flow to the AVM). However, researchers have limited experience treating these conditions because they are rare. In addition, it has been difficult to classify different kinds of AVMs and to develop new treatments for them. This study is designed to increase researchers understanding of AVMs by admitting and following patients diagnosed with the condition. By increasing the amount of patients studied diagnosed with spinal blood vessel abnormalities, researchers can begin to develop new management plans for patients with AVMs. Spinal Arteriovenous Malformations are rare lesions that frequently effect young patients and adults in their most productive years. They cause progressive myelopathy, ultimately causing paraplegia or quadriplegia if untreated. Because they are rare lesions, experience with treating them in sufficient numbers to permit classification of them, investigation of the pathophysiology of myelopathy, and the introduction of new techniques for treatment has been possible in only a very few centers in this country. One essential element of investigation of them is selective spinal arteriography. Since selective spinal arteriography was first introduced for these lesions here at the NIH in the mid 1960's by Drs. John Doppman and Giovanni DiChiro, the NIH has been such a center of expertise for patients with spinal arteriovenous malformations. Because of this, NIH has been, and is, a national referral center for these patients. However, there has never been an approved protocol at the NIH for investigation or treatment of these patients. The purpose of this proposal is to present a plan of investigation and treatment which will serve as a protocol under which to admit these patients and to permit continued accrual of clinical experience with them that will serve to guide others in the management of these patients.

Título OficialEvaluation and Treatment of Patients With Spinal Vascular Abnormalities 
Patrocinador PrincipalNational Institute of Neurological Disorders and Stroke (NINDS)
Última actualización: 2 de julio de 2017
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño
Se reclutarán 120 pacientesNúmero total de participantes que el ensayo clínico espera reclutar.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios
Cualquier sexoSexo biológico de los participantes elegibles para inscribirse.
A partir de 4 añosRango de edades de los participantes que pueden unirse al estudio.
Voluntarios sanos no permitidosIndica si personas sanas, sin la condición que se estudia, pueden participar.
Condiciones
Patología
Arteriovenous Fistula
Arteriovenous Malformation
Spinal Cord Disease
Criterios

* INCLUSION CRITERIA: Adult greater than or equal to 18 years with known or suspected spinal AVM and capacity to provide written informed consent. Child ages 4-18 with known or suspected spinal AVM and with parent/guardian informed consent. EXCLUSION CRITERIA: Unable to tolerate MRI and/or spinal arteriography. Child less than 4 years.



Centros del Estudio

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Este estudio tiene una ubicación
Suspendido
National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, United StatesVer ubicación

Completado1 Centros de Estudio