Clinical trial NCT06214429: Shear Wave Elastography for Carotid Atherosclerotic Plaques
Official title: Evaluation of Atherosclerotic Carotid Plaque Stiffness by Shear Wave Elastography, Greyscale Median, Magnetic Resonance Imaging and Histopathological Analysis: Diagnostic Test Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carotid Atherosclerosis
Lead sponsor: UPECLIN HC FM Botucatu Unesp
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Plaque Stiffness
timeFrame: Through study completion, an average of 2 years.
measure: Plaque Greyscale
timeFrame: Through study completion, an average of 2 years.
measure: Plaque Instability (MRI)
timeFrame: Through study completion, an average of 2 years.
measure: Plaque Instability (Histopathology)
timeFrame: If patient is submitted to carotid endarterectomy.
Secondary outcomes:
measure: Plaque Surface
timeFrame: Through study completion, an average of 2 years.
measure: Anatomic Site of Stenosis
timeFrame: Through study completion, an average of 2 years.
measure: Plaque Correlation with Arterial Wall
timeFrame: Through study completion, an average of 2 years.
measure: Fibrotic Cap
timeFrame: Through study completion, an average of 2 years.
measure: Echolucent Plaque Area
timeFrame: Through study completion, an average of 2 years.
measure: Plaque Echogenicity
timeFrame: Through study completion, an average of 2 years.
measure: Ulceration
timeFrame: Through study completion, an average of 2 years.
measure: Peak Systolic Velocity
timeFrame: Through study completion, an average of 2 years.
measure: End Diastolic Velocity
timeFrame: Through study completion, an average of 2 years.
measure: Velocity Ratio
timeFrame: Through study completion, an average of 2 years.
measure: ECST Morphological Degree of Stenosis
timeFrame: Through study completion, an average of 2 years.
measure: NASCET Morphological Degree of Stenosis
timeFrame: Through study completion, an average of 2 years.
Other outcomes:
Locations:
city: Botucatu
country: Brazil
facility: Sao Paulo State University
state: Sao Paulo
Study officials:
affiliation: São Paulo State University
name: Matheus Bertanha, Ph.D.
role: STUDY_CHAIR
References: