Shear Wave Elastography for Carotid Atherosclerotic Plaques
NCT ID: NCT06214429
Last Updated: 2025-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
43 participants
OBSERVATIONAL
2023-03-01
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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).
Vascular Ultrasound
Complete vascular ultrasound routine in B mode, color mode and Doppler.
Shear Wave Elastography
Vascular ultrasound assisted shear wave elastography of the atherosclerotic plaque.
Greyscale Median
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 Imaging
Assessment of the plaque and carotid residual lumen by magnetic resonance.
Histopathology
Histopathology findings for patients that undergo carotid endarterectomy.
Interventions
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Vascular Ultrasound
Complete vascular ultrasound routine in B mode, color mode and Doppler.
Shear Wave Elastography
Vascular ultrasound assisted shear wave elastography of the atherosclerotic plaque.
Greyscale Median
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 Imaging
Assessment of the plaque and carotid residual lumen by magnetic resonance.
Histopathology
Histopathology findings for patients that undergo carotid endarterectomy.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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UPECLIN HC FM Botucatu Unesp
OTHER
Responsible Party
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Matheus Bertanha, PhD
Professor
Principal Investigators
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Matheus Bertanha, Ph.D.
Role: STUDY_CHAIR
São Paulo State University
Locations
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Sao Paulo State University
Botucatu, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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UPECLIN-MB-7
Identifier Type: -
Identifier Source: org_study_id
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