- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01879397
Pilot Study of Ultrasonic Determined Carotid Plaque Composition (UMP)
Ultrasonic Mapping of Carotid Plaque Composition
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Stroke is a major cause of morbidity and mortality among patients with cardiovascular disease and the major cause of long-term disability in the United States. Current imaging modalities can determine the severity of luminal stenosis resulting from plaque, as in the carotid arteries. However, cerebrovascular accidents (CVAs) are often associated with the rupture of unstable plaques located in regions with a non-significant degree of luminal stenosis. Thus up to 50% of high-risk atherosclerotic plaques may go undetected and untreated. Plaque composition is an additional and perhaps, more important risk factor for CVA rather than stenosis severity alone. Accurate identification of these high-risk, rupture-prone plaques may potentially prevent CVAs in a significant number of patients.
The data collected during this study (ultrasonic backscatter and histologically processed carotid plaque) will provide the basis for a novel algorithm to add plaque composition information to the plaque size and location information that is currently provided by standard ultrasound imaging. The input parameters for the algorithm are derived from two types of non-invasive ultrasound data: spectral parameters and acoustic radiation force impulse (ARFI) data. Spectral parameters are extracted from the frequency content of the backscattered diagnostic ultrasound signals. These are the same signals currently used for imaging, however, imaging relies solely on the strength of the signal to form the image and ignores the spectral information. Thus spectral analysis is an approach to use the information which is sensitive to the number and nature of the scatterers. In contrast ARFI techniques provide information on the stiffness of the tissue. ARFI is based on using a ultrasonic push pulse to slightly move the tissue (displacement on the order of microns) and an image of the relative displacements of the tissue (ARFI image) is created. The ARFI derived data and the spectral parameters will be combined with clinically available measures currently used for diagnosis of carotid stenosis to form the input parameters for the algorithm. In order to train and test the algorithm the plaque removed during surgery will be collected and the histology slides prepared from these plaques. This histology review provides the 'gold' standard for training and testing the algorithm. The majority of these matched sets (67%) will be used for training the algorithm. While the remainder (33%) will provide a test of the accuracy of the algorithm for these types of matched data. The sensitivity and specificity for each tissue type defined during the histology review will be reported.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Ohio
-
Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic
-
-
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
CEA Cohort:
Inclusion Criteria:
- Age ≥40years
- Scheduled to undergo CEA for clinically significant carotid stenosis
- CEA is being performed for carotid stenosis of one or more of the following vessels: Internal Carotid Artery (ICA), distal end of the Common Carotid Artery (CCA), and/or CCA bulb.
Exclusion Criteria:
- Pregnancy
- Prior surgery or intervention involving the carotid artery
- Prior stent in the carotid artery
- Unable to provide informed consent
- CEA for carotid stenosis for proximal CCA only (ICA and distal CCA are not involved)
- CEA is scheduled for non-atherosclerotic vascular disease (e.g.,. fibromuscular dysplasia or systemic vasculitis)
- Unable to understand English language.
Normal Cohort:
Inclusion Criteria
- Age ≥40years
Exclusion Criteria
- Pregnancy
- Prior surgery or intervention involving the carotid artery (including CEA)
- Prior stent in the carotid artery
- Unable to provide informed consent
- Unable to understand English language.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
CEA Group
Subjects with atherosclerotic stenosis of the carotid artery and are scheduled for a clinically indicated Carotid Endarterectomy (CEA) procedure to remove the atherosclerotic plaque.
Prior to CEA procedure, a research ultrasound exam will be performed.
The plaque tissue removed during the CEA will be collected and processed into histological slides.
|
Collection of backscattered ultrasound data during non-invasive ultrasound exam
|
Normal Group
Subjects who are not scheduled for a Carotid Endarterectomy (CEA) procedure and have had no prior carotid artery interventions.
Subjects will have a Research Ultrasound Exam performed.
|
Collection of backscattered ultrasound data during non-invasive ultrasound exam
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Classification Algorithm Error Rate
Periodo de tiempo: Baseline
|
Classification of carotid artery plaque is produced by an algorithm that uses the QUS and ARFI derived parameters corresponding to a given region in the plaque to produce a classification of the plaque region into one of the following: calcium, fibrous, necrotic, or hemorrhagic.
Error rates from both the training and test data sets will be reported.
|
Baseline
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: D. Geoffrey Vince, PhD, The Cleveland Clinic
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (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
- 12-797
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 Research Ultrasound Exam
-
ReCor Medical, Inc.ReclutamientoHipertensiónAlemania, Países Bajos, Bélgica, Francia, Mónaco, Suiza, Reino Unido
-
Abramson Cancer Center of the University of PennsylvaniaTerminadoBulto mamario sintomáticoEstados Unidos
-
Oregon Health and Science UniversityTerminadoSíndrome del túnel carpianoEstados Unidos
-
Arizona Oncology ServicesDesconocidoCáncer de mama localizado | Cáncer de próstata localizado | Pacientes que reciben radioterapia de haz externoEstados Unidos
-
Medical Corps, Israel Defense ForceReclutamientoLesiones Traumáticas | Herida de hemorragiaIsrael
-
Academisch Medisch Centrum - Universiteit van Amsterdam...TerminadoMedición Doppler de la arteria uterinaPaíses Bajos
-
University of CalgaryReclutamientoIntolerancia ortostática | Síndrome de taquicardia posturalCanadá
-
Bryan TompsonTerminadoEl Ritmo o Movimiento Dental OrtodóncicoCanadá
-
CochlearReclutamiento