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
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.
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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Sao Paulo State University | Botucatu | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
UPECLIN HC FM Botucatu Unesp |
Brazil,
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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