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Shear Wave Elastography for Carotid Atherosclerotic Plaques

NCT06214429 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 43

Last updated 2025-04-06

No results posted yet for this study

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 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

Interventions

DIAGNOSTIC_TEST

Vascular Ultrasound

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

DIAGNOSTIC_TEST

Shear Wave Elastography

Vascular ultrasound assisted shear wave elastography of the atherosclerotic plaque.

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.

DIAGNOSTIC_TEST

Magnetic Resonance Imaging

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

DIAGNOSTIC_TEST

Histopathology

Histopathology findings for patients that undergo carotid endarterectomy.

Sponsors & Collaborators

  • UPECLIN HC FM Botucatu Unesp

    lead OTHER

Principal Investigators

  • Matheus Bertanha, Ph.D. · São Paulo State University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2025-06-30
Completion
2025-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06214429 on ClinicalTrials.gov