Shear Wave Elastography for Carotid Atherosclerotic Plaques

Carotid Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06214429
• Other study ID #: UPECLIN-MB-7
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: UPECLIN HC FM Botucatu Unesp
• Contact: Pedro L Mellucci Filho, M.D.
• Phone: +5518997378864
• Email: p.mellucci[@]unesp.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 43
• Est. completion date: December 31, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Diseases
• Carotid Atherosclerosis

Intervention

Diagnostic Test:
• Vascular Ultrasound
Complete vascular ultrasound routine in B mode, color mode and Doppler.
• Shear Wave Elastography
Vascular ultrasound assisted shear wave elastography of the atherosclerotic plaque.
• 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.
• Magnetic Resonance Imaging
Assessment of the plaque and carotid residual lumen by magnetic resonance.
• Histopathology
Histopathology findings for patients that undergo carotid endarterectomy.

Locations

Country	Name	City	State
Brazil	Sao Paulo State University	Botucatu	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
UPECLIN HC FM Botucatu Unesp

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plaque Stiffness	Measured in kilopascal (kPa).	Through study completion, an average of 2 years.
Primary	Plaque Greyscale	Median value of plaque histogram.	Through study completion, an average of 2 years.
Primary	Plaque Instability (MRI)	Degree of plaque instability as proposed by American Heart Association (I to IV).	Through study completion, an average of 2 years.
Primary	Plaque Instability (Histopathology)	Degree of plaque instability as proposed by American Heart Association (I to IV).	If patient is submitted to carotid endarterectomy.
Secondary	Plaque Surface	Regular, irregular or calcified.	Through study completion, an average of 2 years.
Secondary	Anatomic Site of Stenosis	Common carotid artery, bifurcation, internal carotid artery, external carotid artery.	Through study completion, an average of 2 years.
Secondary	Plaque Correlation with Arterial Wall	Concentric or eccentric.	Through study completion, an average of 2 years.
Secondary	Fibrotic Cap	Thin, thick or absent.	Through study completion, an average of 2 years.
Secondary	Echolucent Plaque Area	Present or absent.	Through study completion, an average of 2 years.
Secondary	Plaque Echogenicity	Echolucent, predominantly echolucent, predominantly echogenic, echogenic or calcified.	Through study completion, an average of 2 years.
Secondary	Ulceration	Present or absent.	Through study completion, an average of 2 years.
Secondary	Peak Systolic Velocity	At the site of highest velocity and turbulent flow in centimeters per second (cm/s).	Through study completion, an average of 2 years.
Secondary	End Diastolic Velocity	At the site of highest velocity and turbulent flow in centimeters per second (cm/s).	Through study completion, an average of 2 years.
Secondary	Velocity Ratio	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.
Secondary	ECST Morphological Degree of Stenosis	Percentage of stenosis as measured by the European Carotid Surgery Trial (ECST) protocol (%).	Through study completion, an average of 2 years.
Secondary	NASCET Morphological Degree of Stenosis	Percentage of stenosis as measured by the The North American Symptomatic Carotid Endarterectomy Trial (NASCET) protocol (%).	Through study completion, an average of 2 years.