- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00646672
Aneurysms and Carotid Artery Block in Newborns
Assessment of Cerebral Circulation and Perfusion in Adults After Neonatal Carotid Occlusion
This study will determine the risk of brain aneurysm (abnormal outpouching of a brain artery) in young adults who had their carotid artery tied off as an infant as part of the extracorporeal membrane oxygenation (ECMO) procedure. This procedure is sometimes performed on newborns with lung problems so that they can have oxygen brought to their blood outside the body. ECMO operates similar to a heart-lung machine. Blood drained from the veins has the carbon dioxide removed and oxygen added. The oxygenated blood is then returned to the body through the arteries.
People 18 to 25 years of age who underwent ECMO as an infant at the Children's National Medical Center in Washington, D.C., may be eligible for this study.
Participants undergo the following procedures:
- Medical history and physical and neurological examinations.
- Magnetic resonance imaging (MRI) of the head and neck. MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues. The subject lies in the scanner (a metal cylinder surrounded by a magnetic field) for about 90 minutes, lying still for up to 15 minutes at a time. During part of the procedure, a contrast dye is injected into a vein through a catheter (thin plastic tube) to enhance the images.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Objective:
To assess whether the hemodynamic stress of long-term common carotid artery occlusion can lead to cerebral aneurysm formation in young adults.
Study population:
100 adults 18-25 years of age who underwent common carotid artery (CCA) occlusion as a neonate as part of the extracorporeal membrane oxygenation (ECMO) procedure performed in the setting of pulmonary insufficiency.
Design:
Patients who underwent CCA occlusion as a neonate for ECMO at Children's National Medical Center will be identified and contacted. The study will be explained and informed consent will be obtained. Subjects will undergo outpatient evaluation to include history and physical, magnetic resonance angiography and magnetic resonance imaging of the head.
Outcome measures:
- Cerebrovascular anatomic anomalies such as cerebral aneurysms and persistent fetal circulation pathways, etc.
- Cerebral perfusion asymmetry on MRI.
- Cerebral parenchymal abnormalities such as stroke.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Maryland
-
Bethesda, Maryland, Estados Unidos, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
- INCLUSION CRITERIA:
Subjects must be 18-25 years of age.
Subjects had VA ECMO as a neonate at Children's National Medical Center.
Subjects must be in good health.
Subjects must provide informed, written consent for participation in this study.
EXCLUSION CRITERIA:
Subjects with a history or evidence of mental retardation precluding a written consent unless this consent could be obtained from a legal guardian.
Subjects with a history of reaction to MR contrast media or who are unable to have an MRI.
Subjects who underwent carotid artery reconstruction after neonatal ECMO.
Females who are pregnant or nursing.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Colaboradores e Investigadores
Publicaciones y enlaces útiles
Publicaciones Generales
- Andrews RJ, Spiegel PK. Intracranial aneurysms. Age, sex, blood pressure, and multiplicity in an unselected series of patients. J Neurosurg. 1979 Jul;51(1):27-32. doi: 10.3171/jns.1979.51.1.0027.
- Bartlett RH, Gazzaniga AB, Jefferies MR, Huxtable RF, Haiduc NJ, Fong SW. Extracorporeal membrane oxygenation (ECMO) cardiopulmonary support in infancy. Trans Am Soc Artif Intern Organs. 1976;22:80-93.
- Burt VL, Whelton P, Roccella EJ, Brown C, Cutler JA, Higgins M, Horan MJ, Labarthe D. Prevalence of hypertension in the US adult population. Results from the Third National Health and Nutrition Examination Survey, 1988-1991. Hypertension. 1995 Mar;25(3):305-13. doi: 10.1161/01.hyp.25.3.305.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio
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 (Actual)
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
- 080095
- 08-N-0095
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. .
Ensayos clínicos sobre Trastorno cerebrovascular
-
University of CalgaryThe George Institute for Global Health, AustraliaAún no reclutandoAccidente cerebrovascular isquémico agudo AIS | Accidente cerebrovascular, agudo, accidente cerebrovascular isquémico | Accidente cerebrovascular agudoCanadá, Australia
-
WandercraftReclutamientoTrastornos cerebrovasculares | Apoplejía Isquémica | Accidente cerebrovascular agudo | Accidente cerebrovascular hemorrágico | Hemiparesia | Accidente cerebrovascular | Hemiparesia;Posterior al accidente cerebrovascular/ACV | Accidente cerebrovascular subagudo | Hemiparesia/hemiplejía (debilidad/parálisis...Alemania, Francia, España
-
Dr. med. Carlo CeredaEnte Ospedaliero Cantonale, BellinzonaTerminadoEnfermedad cerebrovascular, accidente cerebrovascular isquémicoSuiza
-
BayerTerminado
-
University of Wisconsin, MadisonNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health...Terminado
-
University of Wisconsin, MadisonNational Institutes of Health (NIH)Terminado
-
Palacky UniversityČeské Budějovice HospitalDesconocidoCirculación cerebrovascularChequia
-
University of Missouri-ColumbiaReclutamientoCirculación cerebrovascularEstados Unidos
-
Academisch Medisch Centrum - Universiteit van Amsterdam...TerminadoCirculación cerebrovascularPaíses Bajos
-
Medical University of ViennaTerminadoCirculación cerebrovascularAustria