An observational study in Internal Carotid Artery Stenosis With Infarction, sponsored by Oslo University Hospital. Active, not recruiting at 1 site in Norway. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-25.
Sponsored by Oslo University Hospital · Observational
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.
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:
Study 2:
SMI and vascular events. Asymptomatic patient's follow-up at 12 months:
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.
339 studies on the registry are indexed under Carotid Stenosis; 81 are open to participants now.
This study's planned enrollment of 30 is below the median of 173 across 144 observational studies indexed under Carotid Stenosis.
Browse Carotid Stenosis studies →Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Raised neovascularization and increased stiffness of the carotid artery wall are correlated to cerebrovascular symptoms and raised level of some plasma markers.
Ultrasound (including SMI, CEUS, SWI), blood test, clinical symptoms and cerebral MRI at inclusion and at one year follow-up
Time frame: one year
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
Ultrasound, blood tests, clinical assessment, cerebral MRI, histology of carotid artery plaques (if treated with carotid endarterectomy)
Time frame: At inclusion
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
Clinical assessment, ultrasound, cerebral MRI, blood tests, histology if removed carotid plaque
Time frame: 1 year
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
Clinical assessment, ultrasound, cerebral MRI, blood tests, histology if removed carotid plaque
Time frame: 1
This study is active, not recruiting, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Oslo University Hospital