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Recruiting NCT06214429

Shear Wave Elastography for Carotid Atherosclerotic Plaques

— Observational Carotid Atherosclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vascular Ultrasound, Shear Wave Elastography, Greyscale Median, Magnetic Resonance Imaging.
Who it may be relevant to
Registry conditions: Carotid Atherosclerosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Plaque Stiffness [Time frame: Through study completion, an average of 2 years.]
  • Plaque Greyscale [Time frame: Through study completion, an average of 2 years.]
  • Plaque Instability (MRI) [Time frame: Through study completion, an average of 2 years.]
  • Plaque Instability (Histopathology) [Time frame: If patient is submitted to carotid endarterectomy.]
Secondary outcome measures (12)
  • Plaque Surface [Time frame: Through study completion, an average of 2 years.]
  • Anatomic Site of Stenosis [Time frame: Through study completion, an average of 2 years.]
  • Plaque Correlation with Arterial Wall [Time frame: Through study completion, an average of 2 years.]
  • Fibrotic Cap [Time frame: Through study completion, an average of 2 years.]
  • Echolucent Plaque Area [Time frame: Through study completion, an average of 2 years.]
  • Plaque Echogenicity [Time frame: Through study completion, an average of 2 years.]
  • Ulceration [Time frame: Through study completion, an average of 2 years.]
  • Peak Systolic Velocity [Time frame: Through study completion, an average of 2 years.]
  • End Diastolic Velocity [Time frame: Through study completion, an average of 2 years.]
  • Velocity Ratio [Time frame: Through study completion, an average of 2 years.]
  • ECST Morphological Degree of Stenosis [Time frame: Through study completion, an average of 2 years.]
  • NASCET Morphological Degree of Stenosis [Time frame: Through study completion, an average of 2 years.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Brazil · 1 center
  • Sao Paulo State University — Botucatu

Identifiers

NCT: NCT06214429 · UPECLIN-MB-7

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗