Shear Wave Elastography for Carotid Atherosclerotic Plaques
ConditionCarotid Atherosclerosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUPECLIN HC FM Botucatu Unesp
About this trial
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
This trial does not accept healthy volunteersQualifiers
Patients with atherosclerotic carotid plaques that develop stenosis superior to 50%.
Disqualifiers
Previous cervical surgery;
Previous cervical radiotherapy;
Stenosis caused by vascular inflammatory diseases;
Pregnant women;
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Vascular Ultrasound
Diagnostic testComplete vascular ultrasound routine in B mode, color mode and Doppler.
Shear Wave Elastography
Diagnostic testVascular ultrasound assisted shear wave elastography of the atherosclerotic plaque.
Greyscale Median
Diagnostic testVascular 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 testAssessment of the plaque and carotid residual lumen by magnetic resonance.
Histopathology
Diagnostic testHistopathology findings for patients that undergo carotid endarterectomy.
Treatment groups
43 Participants
are divided into 1 treatment groupGroup A: Carotid Atherosclerotic Plaque Stenosis >50%5 interventions
Trial outcomes
Primary outcomes
1
Plaque Stiffness
Measured in kilopascal (kPa).
Time frame
Through study completion, an average of 2 years.2
Plaque Greyscale
Median value of plaque histogram.
Time frame
Through study completion, an average of 2 years.3
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.4
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.Secondary outcomes
1
Plaque Surface
Regular, irregular or calcified.
Time frame
Through study completion, an average of 2 years.2
Anatomic Site of Stenosis
Common carotid artery, bifurcation, internal carotid artery, external carotid artery.
Time frame
Through study completion, an average of 2 years.3
Plaque Correlation with Arterial Wall
Concentric or eccentric.
Time frame
Through study completion, an average of 2 years.4
Fibrotic Cap
Thin, thick or absent.
Time frame
Through study completion, an average of 2 years.Sponsors and contacts
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Source ClinicalTrials.gov