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NCT Number: NCT06214429

Shear Wave Elastography for Carotid Atherosclerotic Plaques

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.

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Key information

Conditions

Carotid Atherosclerosis Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vascular Ultrasound

Diagnostic Test

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

Shear Wave Elastography

Diagnostic Test

Vascular ultrasound assisted shear wave elastography of the atherosclerotic plaque.

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.

Magnetic Resonance Imaging

Diagnostic Test

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

Histopathology

Diagnostic Test

Histopathology findings for patients that undergo carotid endarterectomy.

Primary outcomes

  1. Plaque Stiffness

    Time frame: Through study completion, an average of 2 years.

    Measured in kilopascal (kPa).

  2. Plaque Greyscale

    Time frame: Through study completion, an average of 2 years.

    Median value of plaque histogram.

  3. 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).

  4. 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).

Secondary outcomes

  1. Plaque Surface

    Time frame: Through study completion, an average of 2 years.

    Regular, irregular or calcified.

  2. Anatomic Site of Stenosis

    Time frame: Through study completion, an average of 2 years.

    Common carotid artery, bifurcation, internal carotid artery, external carotid artery.

  3. Plaque Correlation with Arterial Wall

    Time frame: Through study completion, an average of 2 years.

    Concentric or eccentric.

  4. Fibrotic Cap

    Time frame: Through study completion, an average of 2 years.

    Thin, thick or absent.

  5. Echolucent Plaque Area

    Time frame: Through study completion, an average of 2 years.

    Present or absent.

  6. Plaque Echogenicity

    Time frame: Through study completion, an average of 2 years.

    Echolucent, predominantly echolucent, predominantly echogenic, echogenic or calcified.

  7. Ulceration

    Time frame: Through study completion, an average of 2 years.

    Present or absent.

  8. 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).

  9. 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).

  10. 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.

  11. 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 (%).

  12. 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 (%).

Study contacts

Contact information is provided by the study sponsor or research team.

Marcone L Sobreira, Ph.D.

CONTACT

[email protected]

+5514997180806

Pedro L Mellucci Filho, M.D.

CONTACT

[email protected]

+5518997378864

Sponsors and collaborators

Lead sponsor

UPECLIN HC FM Botucatu Unesp

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 19, 2024
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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