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.
Study Type
OBSERVATIONAL
Enrollment
43
Complete vascular ultrasound routine in B mode, color mode and Doppler.
Vascular ultrasound assisted shear wave elastography of the atherosclerotic plaque.
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.
Assessment of the plaque and carotid residual lumen by magnetic resonance.
Histopathology findings for patients that undergo carotid endarterectomy.
Sao Paulo State University
Botucatu, São Paulo, Brazil
RECRUITINGPlaque Stiffness
Measured in kilopascal (kPa).
Time frame: Through study completion, an average of 2 years.
Plaque Greyscale
Median value of plaque histogram.
Time frame: Through study completion, an average of 2 years.
Plaque Instability (MRI)
Degree of plaque instability as proposed by American Heart Association (I to IV).
Time frame: Through study completion, an average of 2 years.
Plaque Instability (Histopathology)
Degree of plaque instability as proposed by American Heart Association (I to IV).
Time frame: If patient is submitted to carotid endarterectomy.
Plaque Surface
Regular, irregular or calcified.
Time frame: Through study completion, an average of 2 years.
Anatomic Site of Stenosis
Common carotid artery, bifurcation, internal carotid artery, external carotid artery.
Time frame: Through study completion, an average of 2 years.
Plaque Correlation with Arterial Wall
Concentric or eccentric.
Time frame: Through study completion, an average of 2 years.
Fibrotic Cap
Thin, thick or absent.
Time frame: Through study completion, an average of 2 years.
Echolucent Plaque Area
Present or absent.
Time frame: Through study completion, an average of 2 years.
Plaque Echogenicity
Echolucent, predominantly echolucent, predominantly echogenic, echogenic or calcified.
Time frame: Through study completion, an average of 2 years.
Ulceration
Present or absent.
Time frame: Through study completion, an average of 2 years.
Peak Systolic Velocity
At the site of highest velocity and turbulent flow in centimeters per second (cm/s).
Time frame: Through study completion, an average of 2 years.
End Diastolic Velocity
At the site of highest velocity and turbulent flow in centimeters per second (cm/s).
Time frame: Through study completion, an average of 2 years.
Velocity Ratio
At the site of highest velocity and turbulent flow compared to ipsilateral pre-stenosis common carotid artery.
Time frame: Through study completion, an average of 2 years.
ECST Morphological Degree of Stenosis
Percentage of stenosis as measured by the European Carotid Surgery Trial (ECST) protocol (%).
Time frame: Through study completion, an average of 2 years.
NASCET Morphological Degree of Stenosis
Percentage of stenosis as measured by the The North American Symptomatic Carotid Endarterectomy Trial (NASCET) protocol (%).
Time frame: Through study completion, an average of 2 years.
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