Internal Carotid Artery Stenosis With InfarctionNCT03672955
Advanced Ultrasound Methods in the Assessment of Carotid Plaque Instability
An observational study of Internal Carotid Artery Stenosis With Infarction, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Internal Carotid Artery Stenosis With Infarction
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2016to 1 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Atherosclerotic carotid stenosis >50% with or without cerebrovascular symptoms.
Who cannot join
- Malignancies
- Inflammatory disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Advanced Ultrasound Methods in the Assessment of Carotid Plaque Instability.
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.
Read the 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Secondary outcomes (3)
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)
Measured: 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
Measured: 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
Measured: 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start1 Sep 2016
- Primary completion1 Jan 2021
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internal Carotid Artery Stenosis With InfarctionStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Mona Skjelland, Oslo University Hospital
- Investigators
- Mona Skjelland, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03672955
- Sponsor's protocol ID
- 2014/1468
- Status last verified
- Apr 2022
- First submitted
- 11 Sep 2018
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Ultrasound Methods in the Assessment of Carotid Plaque Instability.
- ClinicalTrials.gov ID
- NCT03672955
- Acronym / sponsor ID
- 2014/1468
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 17 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Atherosclerotic carotid stenosis >50% with or without cerebrovascular symptoms.
Key exclusion criteria (2 listed)
- Malignancies
- Inflammatory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mona Skjelland principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Internal Carotid Artery Stenosis With Infarction, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.