Shear Wave Elastography for Carotid Atherosclerotic Plaques

UPECLIN HC FM Botucatu Unesp

Status: Enrolling

Conditions: Carotid Atherosclerosis

Treatments: Diagnostic Test: Histopathology; Diagnostic Test: Greyscale Median; Diagnostic Test: Magnetic Resonance Imaging; Diagnostic Test: Shear Wave Elastography; Diagnostic Test: Vascular Ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT06214429

UPECLIN-MB-7

Details and patient eligibility

About

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.

Enrollment: 43 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

43 participants in 1 patient group

Carotid Atherosclerotic Plaque Stenosis >50%

Description:

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).

Treatment:

Diagnostic Test: Vascular Ultrasound

Diagnostic Test: Shear Wave Elastography

Diagnostic Test: Magnetic Resonance Imaging

Diagnostic Test: Greyscale Median

Diagnostic Test: Histopathology