Advanced Ultrasound Methods in the Assessment of Carotid Plaque Instability
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|ClinicalTrials.gov Identifier: NCT03672955|
Recruitment Status : Active, not recruiting
First Posted : September 17, 2018
Last Update Posted : October 15, 2018
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.
|Condition or disease|
|Internal Carotid Artery Stenosis With Infarction|
The project will include 3 studies:
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)
- Histological assessments after the removal of plaque at carotid endarterectomy (CEA).
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)
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.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Advanced Ultrasound Methods in the Assessment of Carotid Plaque Instability.|
|Actual Study Start Date :||September 1, 2016|
|Actual Primary Completion Date :||September 1, 2018|
|Estimated Study Completion Date :||January 1, 2020|
- Raised neovascularization and increased stiffness of the carotid artery wall are correlated to cerebrovascular symptoms and raised level of some plasma markers. [ Time Frame: one year ]Ultrasound (including SMI, CEUS, SWI), blood test, clinical symptoms and cerebral MRI at inclusion and at one year follow-up
- 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 [ Time Frame: At inclusion ]Ultrasound, blood tests, clinical assessment, cerebral MRI, histology of carotid artery plaques (if treated with carotid endarterectomy)
- 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 [ Time Frame: 1 year ]Clinical assessment, ultrasound, cerebral MRI, blood tests, histology if removed carotid plaque
- 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 [ Time Frame: 1 ]Clinical assessment, ultrasound, cerebral MRI, blood tests, histology if removed carotid plaque
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03672955
|Oslo University Hospital|
|Oslo, Norway, 0424|
|Principal Investigator:||Mona Skjelland||Oslo University Hospital, Oslo, Norway|