Carotid AtherosclerosisNCT06214429
Shear Wave Elastography for Carotid Atherosclerotic Plaques
An observational study of Carotid Atherosclerosis, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
Trial summary
The goal of this prospective diagnostic accuracy cohort study is to compare the accuracy of carotid atherosclerotic plaques stiffness assessed by shear wave elastography (SWE) with greyscale median values (GSM), magnetic resonance imaging (MRI) and histopathological findings in patients with carotid atherosclerotic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Atherosclerosis
- What is being tested?
- Vascular Ultrasound, Shear Wave Elastography and Greyscale Median
- How many people
- 43 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be composed of outpatient care subjects referred to the Noninvasive Vascular Laboratory of the Hospital das Clinicas da Faculdade de Medicina de Botucatu for vascular appointments or vascular ultrasound assessment for carotid atherosclerotic disease.
Who may be able to join
- Patients with atherosclerotic carotid plaques that develop stenosis superior to 50%.
Who cannot join
- Previous cervical surgery;
- Previous cervical radiotherapy;
- Stenosis caused by vascular inflammatory diseases;
- Pregnant women;
- High carotid bifurcation (inaccessible by vascular ultrasound linear probe);
- Posterior acoustic shadowing that impair morphological evaluation of the plaque.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Sao Paulo State University
Botucatu, São Paulo, 18618-970
Pedro L Mellucci Filho, M.D., +5518997378864, p.mellucci@unesp.br
Marcone L Sobreira, Ph.D., +5514997180806, marcone.lima-sobreira@unesp.br
About this study
Official title: Evaluation of Atherosclerotic Carotid Plaque Stiffness by Shear Wave Elastography, Greyscale Median, Magnetic Resonance Imaging and Histopathological Analysis: Diagnostic Test Study
The goal of this prospective diagnostic accuracy cohort study is to compare the accuracy of carotid atherosclerotic plaques stiffness assessed by shear wave elastography (SWE) with greyscale median values (GSM), magnetic resonance imaging (MRI) and histopathological findings in patients with carotid atherosclerotic plaques causing stenosis above 50%, symptomatic or not.
The main question it aims to answer is: is the plaque stiffness correlatable with GSM values, MRI findings or histopathological findings? Participants will be subjected to a vascular ultrasound study in which the SWE and GSM will be assessed. The second imaging modality for stenosis confirmation will be MRI and patients with confirmed symptomatic stenosis above 50% or assymptomatic stenosis above 70% will be considered for surgery intervention (endarterectomy or angioplasty). Patients that undergo endarterectomy will have the carotid plaques subjected to a histopathological study. The study will not arbitrate about the treatment decision.
- Conditions
- Carotid Atherosclerosis
- Being tested
- Vascular Ultrasound, Shear Wave Elastography, Greyscale Median, Magnetic Resonance Imaging, Histopathology
- Medical subject headings
- Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular UltrasoundDiagnostic test
Complete vascular ultrasound routine in B mode, color mode and Doppler.
Shear Wave ElastographyDiagnostic test
Vascular ultrasound assisted shear wave elastography of the atherosclerotic plaque.
Greyscale MedianDiagnostic test
Vascular ultrasound assisted assessment of the plaque in B mode. The plaque image will be post-processed for the histogram median value for the plaque area.
Magnetic Resonance ImagingDiagnostic test
Assessment of the plaque and carotid residual lumen by magnetic resonance.
HistopathologyDiagnostic test
Histopathology findings for patients that undergo carotid endarterectomy.
| Study group | Role | What they receive |
|---|---|---|
| Carotid Atherosclerotic Plaque Stenosis >50% | Main cohort, composed by subjects with carotid stenosis above 50% confirmed by at least methods (eg. Doppler ultrasound peak systolic velocity > 140cm/s and MRI residual lumen measurement). Receives: Diagnostic Test: Vascular Ultrasound; Diagnostic Test: Shear Wave Elastography; Diagnostic Test: Greyscale Median; Diagnostic Test: Magnetic Resonance Imaging; Diagnostic Test: Histopathology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Stiffness
Measured in kilopascal (kPa).
Measured: Through study completion, an average of 2 years.
Plaque Greyscale
Median value of plaque histogram.
Measured: Through study completion, an average of 2 years.
Plaque Instability (MRI)
Degree of plaque instability as proposed by American Heart Association (I to IV).
Measured: Through study completion, an average of 2 years.
Plaque Instability (Histopathology)
Degree of plaque instability as proposed by American Heart Association (I to IV).
Measured: If patient is submitted to carotid endarterectomy.
Secondary outcomes (12)
Plaque Surface
Regular, irregular or calcified.
Measured: Through study completion, an average of 2 years.
Anatomic Site of Stenosis
Common carotid artery, bifurcation, internal carotid artery, external carotid artery.
Measured: Through study completion, an average of 2 years.
Plaque Correlation with Arterial Wall
Concentric or eccentric.
Measured: Through study completion, an average of 2 years.
Fibrotic Cap
Thin, thick or absent.
Measured: Through study completion, an average of 2 years.
Echolucent Plaque Area
Present or absent.
Measured: Through study completion, an average of 2 years.
Plaque Echogenicity
Echolucent, predominantly echolucent, predominantly echogenic, echogenic or calcified.
Measured: Through study completion, an average of 2 years.
Ulceration
Present or absent.
Measured: Through study completion, an average of 2 years.
Peak Systolic Velocity
At the site of highest velocity and turbulent flow in centimeters per second (cm/s).
Measured: Through study completion, an average of 2 years.
End Diastolic Velocity
At the site of highest velocity and turbulent flow in centimeters per second (cm/s).
Measured: Through study completion, an average of 2 years.
Velocity Ratio
At the site of highest velocity and turbulent flow compared to ipsilateral pre-stenosis common carotid artery.
Measured: Through study completion, an average of 2 years.
ECST Morphological Degree of Stenosis
Percentage of stenosis as measured by the European Carotid Surgery Trial (ECST) protocol (%).
Measured: Through study completion, an average of 2 years.
NASCET Morphological Degree of Stenosis
Percentage of stenosis as measured by the The North American Symptomatic Carotid Endarterectomy Trial (NASCET) protocol (%).
Measured: Through study completion, an average of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start1 Mar 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid AtherosclerosisStudies of the same condition, open and under way.
- 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
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UPECLIN HC FM Botucatu Unesp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matheus Bertanha, PhD, UPECLIN HC FM Botucatu Unesp
- Investigators
- Matheus Bertanha, Ph.D., Study chair, São Paulo State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214429
- Sponsor's protocol ID
- UPECLIN-MB-7
- Status last verified
- Apr 2025
- First submitted
- 28 Dec 2023
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Atherosclerotic Carotid Plaque Stiffness by Shear Wave Elastography, Greyscale Median, Magnetic Resonance Imaging and Histopathological Analysis: Diagnostic Test Study
- ClinicalTrials.gov ID
- NCT06214429
- Acronym / sponsor ID
- UPECLIN-MB-7
- Conditions
- Carotid Atherosclerosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- UPECLIN HC FM Botucatu UnespUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Jan 2024 (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 goal of this prospective diagnostic accuracy cohort study is to compare the accuracy of carotid atherosclerotic plaques stiffness assessed by shear wave elastography (SWE) with greyscale median values (GSM), magnetic resonance imaging (MRI) and histopathological findings in patients with carotid atherosclerotic plaques causing stenosis above 50%, symptomatic or not.
The main question it aims to answer is: is the plaque stiffness correlatable with GSM values, MRI findings or histopathological findings? Participants will be subjected to a vascular ultrasound study in which the SWE and GSM will be assessed. The second imaging modality for stenosis confirmation will be MRI and patients with confirmed symptomatic stenosis above 50% or assymptomatic stenosis above 70% will be considered for surgery intervention (endarterectomy or angioplasty). Patients that undergo endarterectomy will have the carotid plaques subjected to a histopathological study. The study will not arbitrate about the treatment decision.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carotid Atherosclerotic Plaque Stenosis >50% | – | Diagnostic Test: Vascular Ultrasound, Diagnostic Test: Shear Wave Elastography, Diagnostic Test: Greyscale Median, Diagnostic Test: Magnetic Resonance Imaging, Diagnostic Test: HistopathologyMain cohort, composed by subjects with carotid stenosis above 50% confirmed by at least methods (eg. Doppler ultrasound peak systolic velocity > 140cm/s and MRI residual lumen measurement). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be composed of outpatient care subjects referred to the Noninvasive Vascular Laboratory of the Hospital das Clinicas da Faculdade de Medicina de Botucatu for vascular appointments or vascular ultrasound assessment for carotid atherosclerotic disease.
Key inclusion criteria (1 listed)
- Patients with atherosclerotic carotid plaques that develop stenosis superior to 50%.
Key exclusion criteria (6 listed)
- Previous cervical surgery;
- Previous cervical radiotherapy;
- Stenosis caused by vascular inflammatory diseases;
- Pregnant women;
- High carotid bifurcation (inaccessible by vascular ultrasound linear probe);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vascular UltrasoundComplete vascular ultrasound routine in B mode, color mode and Doppler. | Diagnostic test | Carotid Atherosclerotic Plaque Stenosis >50% |
| Shear Wave ElastographyVascular ultrasound assisted shear wave elastography of the atherosclerotic plaque. | Diagnostic test | Carotid Atherosclerotic Plaque Stenosis >50% |
| Greyscale MedianVascular ultrasound assisted assessment of the plaque in B mode. The plaque image will be post-processed for the histogram median value for the plaque area. | Diagnostic test | Carotid Atherosclerotic Plaque Stenosis >50% |
| Magnetic Resonance ImagingAssessment of the plaque and carotid residual lumen by magnetic resonance. | Diagnostic test | Carotid Atherosclerotic Plaque Stenosis >50% |
| HistopathologyHistopathology findings for patients that undergo carotid endarterectomy. | Diagnostic test | Carotid Atherosclerotic Plaque Stenosis >50% |
Primary outcome
Plaque Stiffness
Time frame: Through study completion, an average of 2 years.
Measured in kilopascal (kPa).
Plaque Greyscale
Time frame: Through study completion, an average of 2 years.
Median value of plaque histogram.
Plaque Instability (MRI)
Time frame: Through study completion, an average of 2 years.
Degree of plaque instability as proposed by American Heart Association (I to IV).
Plaque Instability (Histopathology)
Time frame: If patient is submitted to carotid endarterectomy.
Degree of plaque instability as proposed by American Heart Association (I to IV).
12 secondary outcomes
Plaque Surface
Time frame: Through study completion, an average of 2 years.
Anatomic Site of Stenosis
Time frame: Through study completion, an average of 2 years.
Plaque Correlation with Arterial Wall
Time frame: Through study completion, an average of 2 years.
Fibrotic Cap
Time frame: Through study completion, an average of 2 years.
Echolucent Plaque Area
Time frame: Through study completion, an average of 2 years.
Plaque Echogenicity
Time frame: Through study completion, an average of 2 years.
Ulceration
Time frame: Through study completion, an average of 2 years.
Peak Systolic Velocity
Time frame: Through study completion, an average of 2 years.
End Diastolic Velocity
Time frame: Through study completion, an average of 2 years.
Velocity Ratio
Time frame: Through study completion, an average of 2 years.
ECST Morphological Degree of Stenosis
Time frame: Through study completion, an average of 2 years.
NASCET Morphological Degree of Stenosis
Time frame: Through study completion, an average of 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Carotid Atherosclerosis
Recruiting
Predicting High-Risk Carotid Plaque: Integrating radioMics and biomEchanics
Carotid Artery, Carotid Arteriosclerosis
Not yet recruiting
Effects of Rosa Roxburghii Tratt Freeze-Dried Powder on Carotid Atherosclerotic Plaques: A Real-World Study
Carotid Artery Plaques, Atherosclerosis
RecruitingPhase 2
Colchicine for Primary Prevention of Cardiovascular Disease in Adults With Type 2 Diabetes
Type 2 Diabetes Mellitus (T2DM), Atherosclerosis
Enrolling by invitationObservational study
The Role Oral Microbiome in the Development and Progression of Aorta Aneurysm and Carotid Atherosclerosis
Aorta Aneurysm, Carotid Arteriosclerosis
Not yet recruitingPhase 4
RESCUE: PCSK9 Inhibitors for Carotid Vulnerable Plaque Remodeling
Atherosclerosis Cerebral, Carotid Plaque
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.
Matheus Bertanha, Ph.D. study chair
São Paulo State University
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 Carotid Atherosclerosis, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
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 6 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: looking for participants now, as of the sponsor's last update on 6 Apr 2025. 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pedro L Mellucci Filho, M.D. (+5518997378864, p.mellucci@unesp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque Stiffness (time frame: Through study completion, an average of 2 years.). The study lists 4 primary outcomes in all. 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 6 Apr 2025.