Shear Wave Elastography for Carotid Atherosclerotic Plaques

NCT06214429 | Recruiting

• 1 other identifier: UPECLIN-MB-7
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Atherosclerosis

Outcome Measures

Primary Outcomes (4)

• Plaque Stiffness

  Measured in kilopascal (kPa).

  Through study completion, an average of 2 years.

• Plaque Greyscale

  Median value of plaque histogram.

  Through study completion, an average of 2 years.

• Plaque Instability (MRI)

  Degree of plaque instability as proposed by American Heart Association (I to IV).

  Through study completion, an average of 2 years.

• Plaque Instability (Histopathology)

  Degree of plaque instability as proposed by American Heart Association (I to IV).

  If patient is submitted to carotid endarterectomy.

Secondary Outcomes (12)

• Plaque Surface

  Through study completion, an average of 2 years.

• Anatomic Site of Stenosis

  Through study completion, an average of 2 years.

• Plaque Correlation with Arterial Wall

  Through study completion, an average of 2 years.

• Fibrotic Cap

  Through study completion, an average of 2 years.

• Echolucent Plaque Area

  Through study completion, an average of 2 years.

Study Arms (1)

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

Interventions

Vascular Ultrasound DIAGNOSTIC_TEST

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

Carotid Atherosclerotic Plaque Stenosis >50%

Shear Wave Elastography DIAGNOSTIC_TEST

Vascular ultrasound assisted shear wave elastography of the atherosclerotic plaque.

Carotid Atherosclerotic Plaque Stenosis >50%

Greyscale Median DIAGNOSTIC_TEST

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.

Carotid Atherosclerotic Plaque Stenosis >50%

Magnetic Resonance Imaging DIAGNOSTIC_TEST

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

Carotid Atherosclerotic Plaque Stenosis >50%

Histopathology DIAGNOSTIC_TEST

Histopathology findings for patients that undergo carotid endarterectomy.

Carotid Atherosclerotic Plaque Stenosis >50%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with atherosclerotic carotid plaques that develop stenosis superior to 50%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UPECLIN HC FM Botucatu Unesp: lead

Study Sites (1)

Sao Paulo State University

Botucatu, São Paulo, 18618-970, Brazil

RECRUITING

MeSH Terms

Conditions

Carotid Artery Diseases

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Matheus Bertanha, Ph.D.

  São Paulo State University

  STUDY CHAIR

Central Study Contacts

Pedro L Mellucci Filho, M.D.

CONTACT

+5518997378864; p.mellucci@unesp.br

Marcone L Sobreira, Ph.D.

CONTACT

+5514997180806; marcone.lima-sobreira@unesp.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: January 19, 2024
• Study Start: March 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)