Clinical trial NCT03672955: Advanced Ultrasound Methods in the Assessment of Carotid Plaque Instability
Official title: Advanced Ultrasound Methods in the Assessment of Carotid Plaque Instability.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Internal Carotid Artery Stenosis With Infarction
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2018-09-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: • All patients with an atherosclerotic carotid stenosis \>50% admitting department of neurology, Oslo University Hospital, Rikshospitalet as an in-patient or an out-patient will be considered for inclusion

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Atherosclerotic carotid stenosis \>50% with or without cerebrovascular symptoms.

Exclusion Criteria:

* Malignancies
* Inflammatory disease

Primary outcomes:
measure: Raised neovascularization and increased stiffness of the carotid artery wall are correlated to cerebrovascular symptoms and raised level of some plasma markers.
timeFrame: one year
Secondary outcomes:
measure: 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
timeFrame: At inclusion
measure: 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
timeFrame: 1 year
measure: 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
timeFrame: 1
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital, Oslo, Norway
name: Mona Skjelland
role: PRINCIPAL_INVESTIGATOR
References: