Cognitive Outcome After Carotid Surgery
22 de noviembre de 2019 actualizado por: Lahey Clinic
The purpose of this study is to understand how carotid endarterectomy (CEA) or percutaneous carotid angioplasty and stenting (CAS) affect memory and thinking resulting in improving or worsening of thinking or memory.
There have been many studies on this subject, some finding that certain patients gain improvement in their brain function and others might get worse.
The goal of this study is to discover which patients are more likely to have improved cognitive functioning.
Carotid endarterectomy (CEA) and percutaneous carotid angioplasty and stenting (CAS) are not investigational and are an accepted treatment for your condition.
In addition, subjects that choose not to undergo surgery will also be included in this study.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
At the present time, large multi-center clinical trials support the use of carotid revascularization for symptomatic carotid stenosis and for asymptomatic carotid stenosis (greater than 60%) to prevent stroke. Guidelines supporting the use of carotid endarterectomy for asymptomatic stenosis are based largely on the Asymptomatic Carotid Atherosclerosis Study (ACAS) which reported a 47% relative risk reduction for ipsilateral stroke or death in patients randomized to surgery compared to best medical management over 5 years. These data were further substantiated by the recent publication of the Medical Research Council Asymptomatic Carotid Surgery (ACST) trial results (1); however, both trials estimated that at least 40 operative procedures were required to prevent a single disabling stroke or death in one patient after 5 years (2). These data underscore the importance of understanding the cognitive risks of carotid revascularization and developing strategies to limit factors that contribute to this risk especially in asymptomatic patients.
The purpose of this study is to better understand the effect of carotid revascularization (using either carotid endarterectomy (CEA) or percutaneous carotid angioplasty and stenting (CAS)) on cognitive outcome by prospectively collecting cerebral blood flow data and cognitive testing data prior to and after carotid revascularization procedures.
Tipo de estudio
De observación
Inscripción (Anticipado)
56
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
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Massachusetts
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Burlington, Massachusetts, Estados Unidos, 01805
- Lahey Clinic, Inc.
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New York
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Buffalo, New York, Estados Unidos, 14203
- University of Buffalo Neurosurgery (UBNS)
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Stony Brook, New York, Estados Unidos, 11794-8122
- StonyBrook
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra de probabilidad
Población de estudio
Patients with unilateral, asymptomatic, significant carotid artery stenosis who are ≥18 years of age who do not present with past or current significant cerebrovascular and neuropsychological disease.
Descripción
Inclusion Criteria:
- Patients with asymptomatic (defined as no symptoms in past 6 months) carotid stenosis
- Patients with hemodynamically significant carotid artery stenosis (according to CREST criteria: ≥ 60% by angiography, OR ≥ 70% by ultrasound, OR ≥ 80% by CTA or MRA)
Exclusion Criteria:
- Patients with prior large vessel infarct
- Patients with intracranial stenosis
- Patients with major depression
- Patients with Alzheimer disease (clinically defined or Wechsler IQ <80)
- Patients who have had previous ipsilateral carotid surgery
- Patients with baseline dementia defined as: Mini-Mental Status Examination score < 21 OR Mini-Mental score ≥21 AND Baseline HVLT scores more than 3 standard deviations below normal or FAS scores more than 2 standard deviations below normal OR other clinical symptoms that were not as evident on direct cognitive assessment (e.g. sundowning, getting lost while driving).
Note: A control group would be comprised of about 15 patients who meet eligibility criteria as above, but elect to have their condition followed rather than undergo revascularization.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
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Carotid Endarterectomy (CEA)
Surgical Revascularization- Carotid Endarterectomy (CEA)
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Carotid Angioplasty and Stenting (CAS)
Surgical Revascularization- Carotid Angioplasty and Stenting (CAS)
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Control Group- Medical Management
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Measurement of change in cerebral blood flow from pre-op/baseline to 1 month post-operatively.
Periodo de tiempo: preoperative/baseline and 1 month postoperative/from baseline
|
Quantitative flow MRA studies will be performed pre-operative and postoperative for those undergoing carotid revascularization surgery.
Those not undergoing surgery will have this test upon study enrollment and approximately 1 month from study enrollment date.
|
preoperative/baseline and 1 month postoperative/from baseline
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mini Mental Status Exam
Periodo de tiempo: Pre-operative/baseline
|
A standardized cognitive measure
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Pre-operative/baseline
|
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Trail Making- Part A
Periodo de tiempo: Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline
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Standardized cognitive measure that assesses verbal fluency
|
Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline
|
|
Trail Making- Part B
Periodo de tiempo: Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline
|
Standardized cognitive measure that assesses executive functioning
|
Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline
|
|
Hopkins Verbal Learning Test (HVLT)
Periodo de tiempo: Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline
|
Standardized measure to assess new learning and memory
|
Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline
|
|
D-KEFS Verbal Fluency Test (FAS)
Periodo de tiempo: Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline
|
Standardized measure to assess letter fluency
|
Preoperative/baseline, 1 month postoperative/post baseline, 6 months postoperative/post baseline, and 1 year postoperative/post baseline
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Zoher Ghogawala, MD, Lahey Clinic, Inc.
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Halliday A, Mansfield A, Marro J, Peto C, Peto R, Potter J, Thomas D; MRC Asymptomatic Carotid Surgery Trial (ACST) Collaborative Group. Prevention of disabling and fatal strokes by successful carotid endarterectomy in patients without recent neurological symptoms: randomised controlled trial. Lancet. 2004 May 8;363(9420):1491-502. doi: 10.1016/S0140-6736(04)16146-1. Erratum In: Lancet. 2004 Jul 31;364(9432):416.
- Rothwell PM, Goldstein LB. Carotid endarterectomy for asymptomatic carotid stenosis: asymptomatic carotid surgery trial. Stroke. 2004 Oct;35(10):2425-7. doi: 10.1161/01.STR.0000141706.50170.a7. Epub 2004 Aug 26. No abstract available.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de abril de 2014
Finalización primaria (Actual)
1 de noviembre de 2019
Finalización del estudio (Actual)
1 de noviembre de 2019
Fechas de registro del estudio
Enviado por primera vez
15 de abril de 2014
Primero enviado que cumplió con los criterios de control de calidad
16 de abril de 2014
Publicado por primera vez (Estimar)
21 de abril de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de noviembre de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
22 de noviembre de 2019
Última verificación
1 de marzo de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2013-009
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. .