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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
Sponsor:
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Mona Skjelland, Oslo University Hospital

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.


Condition or disease
Internal Carotid Artery Stenosis With Infarction

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.


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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 ]
    Clinical assessment, ultrasound, cerebral MRI, blood tests, histology if removed carotid plaque


Biospecimen Retention:   Samples Without DNA
Carotid artery plaques removed by treatment with carotid endarterectomy.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Malignancies
  • Inflammatory disease

Information from the National Library of Medicine

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


Locations
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Norway
Oslo University Hospital
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
University of Oslo
Investigators
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Principal Investigator: Mona Skjelland Oslo University Hospital, Oslo, Norway

Additional Information:

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Responsible Party: Mona Skjelland, Consultant, Associate professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03672955     History of Changes
Other Study ID Numbers: 2014/1468
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infarction
Carotid Stenosis
Ischemia
Pathologic Processes
Necrosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases