Advanced Ultrasound Methods in the Assessment of Carotid Plaque Instability

NCT ID: NCT03672955

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2026-01-01

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.

Conditions

Internal Carotid Artery Stenosis With Infarction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Malignancies
• Inflammatory disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oslo

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mona Skjelland

Consultant, Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mona Skjelland

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital, Oslo, Norway

Locations

Oslo University Hospital

Oslo, , Norway

Countries

Norway

Other Identifiers

2014/1468

Identifier Type: -

Identifier Source: org_study_id