Shear Wave Elastography for Carotid Atherosclerotic Plaques

April 2, 2025 updated by: Matheus Bertanha, PhD, UPECLIN HC FM Botucatu Unesp

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Sao Paulo
      • Botucatu, Sao Paulo, Brazil, 18618-970

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will be composed of outpatient care subjects referred to the Noninvasive Vascular Laboratory of the Hospital das Clinicas da Faculdade de Medicina de Botucatu for vascular appointments or vascular ultrasound assessment for carotid atherosclerotic disease.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UPECLIN HC FM Botucatu Unesp

Investigators

  • Study Chair: Matheus Bertanha, Ph.D., São Paulo State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 28, 2023

First Submitted That Met QC Criteria

January 9, 2024

First Posted (Actual)

January 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

April 2, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPECLIN-MB-7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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