Advanced Ultrasound Methods in the Assessment of Carotid Plaque Instability

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EstadoActivo, no reclutando

Patrocinadores

Oslo University Hospital

Colaboradores

University of Oslo

ENSAYO CLÍNICO: NCT03672955

BioSeek: NCT03672955

Palabras clave

Abstracto

The primary aim of this project is to assess if advanced ultrasound methods such as SMI (Superb microvascular Imaging) and SWE (Shear Wave Elastography) can identify intraplaque neovascularization and plaque tissue stiffness in carotid artery plaques and relate these results to ipsilateral cerebrovascular symptoms.

The secondary aim of this project is to assess the level of agreement between the structural plaque characteristics assessed by advanced ultrasound examinations such as SMI, SWE, CEUS (Contrast enhanced ultrasound), GSM (Plaque gray-scale-median) and carotid MRI, metabolic activity of plaque assessed by 18F-FDG PET/CT with histology as the gold standard. Findings from the methods mentioned above will be related to cerebrovascular symptoms, blood tests (cholesterol-tot, LDL, HDL, CRP, leukocytes, glucose, HbA1c) and other cardiovascular risk factors at inclusion and upon 1 year follow up.

Descripción

The project will include 3 studies:

Study 1:

Analyse the correlation between SMI assessed neovascularization and degree of stenosis in symptomatic patients with high-grade (>50%) carotid stenosis versus asymptomatic patients with high-grade (>50%) carotid stenosis.

All patients upon inclusion will undergo:

- Clinical, neurological evaluation

- Blood tests

- SMI, CEUS and SWE ultrasound

- Carotid MRI

- PET (subgroup)

- DW-MRI

- Histological assessments after the removal of plaque at carotid endarterectomy (CEA).

Study 2:

SMI and vascular events. Asymptomatic patient's follow-up at 12 months:

- Clinical neurological evaluation

- Blood test

- SMI, CEUS, SWE ultrasound

- Carotid MRI

- PET (subgroup)

Study 3:

This study will use the same patient pool described in study 1 undergoing the previously described procedural examinations upon inclusion and at one year follow up. Quantification of stiffness/elasticity in the artery wall will be performed and compared to plaque echogenicity measured as GSM . These results will be correlated to histology of the carotid plaque after trombendarterectomy, risk markers in blood (lipids, HbA1c, CRP, leukocytes), other cardiovascular risk markers (hypertension, diabetes, nicotine) and cerebrovascular symptoms.

fechas

Verificado por última vez:	09/30/2018
Primero enviado:	09/10/2018
Inscripción estimada enviada:	09/13/2018
Publicado por primera vez:	09/16/2018
Última actualización enviada:	10/09/2018
Última actualización publicada:	10/14/2018
Fecha de inicio real del estudio:	08/31/2016
Fecha estimada de finalización primaria:	08/31/2018
Fecha estimada de finalización del estudio:	12/31/2019

Condición o enfermedad

Internal Carotid Artery Stenosis With Infarction

Fase

Criterio de elegibilidad

Edades elegibles para estudiar	18 Years A 18 Years
Sexos elegibles para estudiar	All
Método de muestreo	Non-Probability Sample
Acepta voluntarios saludables	si
Criterios	Inclusion Criteria: - Atherosclerotic carotid stenosis >50% with or without cerebrovascular symptoms. Exclusion Criteria: - Malignancies - Inflammatory disease

Salir

Medidas de resultado primarias

1. Raised neovascularization and increased stiffness of the carotid artery wall are correlated to cerebrovascular symptoms and raised level of some plasma markers. [one year]

Ultrasound (including SMI, CEUS, SWI), blood test, clinical symptoms and cerebral MRI at inclusion and at one year follow-up

Medidas de resultado secundarias

1. Increased neovascularization in the carotid artery wall assessed by SMI ultrasound is correlated to cerebrovascular symptoms, ischemic lesions on cerebral MR, increased level of some plasma markers and increased vascularization on carotid plaques [At inclusion]

Ultrasound, blood tests, clinical assessment, cerebral MRI, histology of carotid artery plaques (if treated with carotid endarterectomy)

2. Increased neovascularization in the carotid artery wall assessed by SMI ultrasound is correlated to cerebrovascular symptoms, ischemic lesions on cerebral MR and increased level of some plasma markers at one year follow-up [1 year]

Clinical assessment, ultrasound, cerebral MRI, blood tests, histology if removed carotid plaque

3. Increased stiffness in the carotid artery wall assessed by ultrasound (GSM) is correlated to cerebrovascular symptoms and increased level of some plasma markers at one year follow-up [1]