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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carotid Atherosclerotic Plaque Stenosis >50% | Main cohort, composed by subjects with carotid stenosis above 50% confirmed by at least methods (eg. Doppler ultrasound peak systolic velocity > 140cm/s and MRI residual lumen measurement). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vascular Ultrasound | Diagnostic Test | Complete vascular ultrasound routine in B mode, color mode and Doppler. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plaque Stiffness | Measured in kilopascal (kPa). | Through study completion, an average of 2 years. |
| Plaque Greyscale | Median value of plaque histogram. | Through study completion, an average of 2 years. |
| Plaque Instability (MRI) | Degree of plaque instability as proposed by American Heart Association (I to IV). | Through study completion, an average of 2 years. |
| Plaque Instability (Histopathology) | Degree of plaque instability as proposed by American Heart Association (I to IV). | If patient is submitted to carotid endarterectomy. |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque Surface | Regular, irregular or calcified. | Through study completion, an average of 2 years. |
| Anatomic Site of Stenosis | Common carotid artery, bifurcation, internal carotid artery, external carotid artery. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pedro L Mellucci Filho, M.D. | Contact | +5518997378864 | p.mellucci@unesp.br | |
| Marcone L Sobreira, Ph.D. | Contact | +5514997180806 | marcone.lima-sobreira@unesp.br |
| Name | Affiliation | Role |
|---|---|---|
| Matheus Bertanha, Ph.D. | São Paulo State University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sao Paulo State University | Recruiting | Botucatu | São Paulo | 18618-970 | Brazil |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 4, 2026 | |
| Reset | May 28, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 4, 2026 | May 28, 2026 |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Shear Wave Elastography | Diagnostic Test | Vascular ultrasound assisted shear wave elastography of the atherosclerotic plaque. |
|
| Greyscale Median | Diagnostic Test | 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 | Diagnostic Test | Assessment of the plaque and carotid residual lumen by magnetic resonance. |
|
| Histopathology | Diagnostic Test | Histopathology findings for patients that undergo carotid endarterectomy. |
|
| Through study completion, an average of 2 years. |
| Plaque Correlation with Arterial Wall | Concentric or eccentric. | Through study completion, an average of 2 years. |
| Fibrotic Cap | Thin, thick or absent. | Through study completion, an average of 2 years. |
| Echolucent Plaque Area | Present or absent. | Through study completion, an average of 2 years. |
| Plaque Echogenicity | Echolucent, predominantly echolucent, predominantly echogenic, echogenic or calcified. | Through study completion, an average of 2 years. |
| Ulceration | Present or absent. | 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). | 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). | 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. | 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 (%). | 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 (%). | Through study completion, an average of 2 years. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |