Shear Wave Elastography for Carotid Atherosclerotic Plaques

Recruiting

• Conditions: Carotid Atherosclerosis
• Interventions: Diagnostic Test: Vascular Ultrasound; Diagnostic Test: Shear Wave Elastography; Diagnostic Test: Greyscale Median; Diagnostic Test: Magnetic Resonance Imaging; Diagnostic Test: Histopathology

• Registration Number: NCT06214429
• Lead Sponsor: UPECLIN HC FM Botucatu Unesp

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-01
• Study First Submitted: 2023-12-28
• Study First Submitted QC: 2024-01-09
• Study First Posted: 2024-01-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-06
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 43

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Carotid Atherosclerotic Plaque Stenosis >50%	Greyscale Median	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).
Carotid Atherosclerotic Plaque Stenosis >50%	Magnetic Resonance Imaging	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).
Carotid Atherosclerotic Plaque Stenosis >50%	Vascular Ultrasound	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).
Carotid Atherosclerotic Plaque Stenosis >50%	Shear Wave Elastography	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).
Carotid Atherosclerotic Plaque Stenosis >50%	Histopathology	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).

Primary Outcome Measures

Name	Time	Method
Plaque Stiffness	Through study completion, an average of 2 years.	Measured in kilopascal (kPa).
Plaque Greyscale	Through study completion, an average of 2 years.	Median value of plaque histogram.
Plaque Instability (MRI)	Through study completion, an average of 2 years.	Degree of plaque instability as proposed by American Heart Association (I to IV).
Plaque Instability (Histopathology)	If patient is submitted to carotid endarterectomy.	Degree of plaque instability as proposed by American Heart Association (I to IV).

Secondary Outcome Measures

Name	Time	Method
Echolucent Plaque Area	Through study completion, an average of 2 years.	Present or absent.
Anatomic Site of Stenosis	Through study completion, an average of 2 years.	Common carotid artery, bifurcation, internal carotid artery, external carotid artery.
Plaque Correlation with Arterial Wall	Through study completion, an average of 2 years.	Concentric or eccentric.
Fibrotic Cap	Through study completion, an average of 2 years.	Thin, thick or absent.
Peak Systolic Velocity	Through study completion, an average of 2 years.	At the site of highest velocity and turbulent flow in centimeters per second (cm/s).
ECST Morphological Degree of Stenosis	Through study completion, an average of 2 years.	Percentage of stenosis as measured by the European Carotid Surgery Trial (ECST) protocol (%).
End Diastolic Velocity	Through study completion, an average of 2 years.	At the site of highest velocity and turbulent flow in centimeters per second (cm/s).
Velocity Ratio	Through study completion, an average of 2 years.	At the site of highest velocity and turbulent flow compared to ipsilateral pre-stenosis common carotid artery.
Plaque Surface	Through study completion, an average of 2 years.	Regular, irregular or calcified.
Plaque Echogenicity	Through study completion, an average of 2 years.	Echolucent, predominantly echolucent, predominantly echogenic, echogenic or calcified.
Ulceration	Through study completion, an average of 2 years.	Present or absent.
NASCET Morphological Degree of Stenosis	Through study completion, an average of 2 years.	Percentage of stenosis as measured by the The North American Symptomatic Carotid Endarterectomy Trial (NASCET) protocol (%).

Trial Locations

Locations (1)

Sao Paulo State University; 🇧🇷 Botucatu, Sao Paulo, Brazil