NCT06214429

Shear Wave Elastography for Carotid Atherosclerotic Plaques

Evaluation of Atherosclerotic Carotid Plaque Stiffness by Shear Wave Elastography, Greyscale Median, Magnetic Resonance Imaging and Histopathological Analysis: Diagnostic Test Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 43 (estimated)
• Sponsor: UPECLIN HC FM Botucatu Unesp · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-06-30
• Completion: 2025-12-31
• First posted: 2024-01-19
• Last updated: 2025-04-06

Locations

1 site across 1 country: Brazil