Shear Wave Elastography for Carotid Atherosclerotic Plaques

NCT ID: NCT06214429

Last Updated: 2025-04-06

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Carotid Atherosclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DIAGNOSTIC_TEST

Complete vascular ultrasound routine in B mode, color mode and Doppler.

Shear Wave Elastography

Intervention Type DIAGNOSTIC_TEST

Vascular ultrasound assisted shear wave elastography of the atherosclerotic plaque.

Greyscale Median

Intervention Type DIAGNOSTIC_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 Imaging

Intervention Type DIAGNOSTIC_TEST

Assessment of the plaque and carotid residual lumen by magnetic resonance.

Histopathology

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

Shear Wave Elastography

Vascular ultrasound assisted shear wave elastography of the atherosclerotic plaque.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

Magnetic Resonance Imaging

Assessment of the plaque and carotid residual lumen by magnetic resonance.

Intervention Type DIAGNOSTIC_TEST

Histopathology

Histopathology findings for patients that undergo carotid endarterectomy.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients with atherosclerotic carotid plaques that develop stenosis superior to 50%.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UPECLIN HC FM Botucatu Unesp

OTHER

Sponsor Role lead

Responsible Party

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Matheus Bertanha, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Pedro L Mellucci Filho, M.D.

Role: CONTACT

+5518997378864

Marcone L Sobreira, Ph.D.

Role: CONTACT

+5514997180806

Facility Contacts

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Pedro L Mellucci Filho, M.D.

Role: primary

+5518997378864

Marcone L Sobreira, Ph.D.

Role: backup

+5514997180806

Other Identifiers

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UPECLIN-MB-7

Identifier Type: -

Identifier Source: org_study_id

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