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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06214429
Other study ID # UPECLIN-MB-7
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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.
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