Carotid Atherosclerosis
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTVascular Ultrasound
Complete vascular ultrasound routine in B mode, color mode and Doppler.
DIAGNOSTIC_TESTShear Wave Elastography
Vascular ultrasound assisted shear wave elastography of the atherosclerotic plaque.
DIAGNOSTIC_TESTGreyscale 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.
DIAGNOSTIC_TESTMagnetic Resonance Imaging
Assessment of the plaque and carotid residual lumen by magnetic resonance.
DIAGNOSTIC_TESTHistopathology
Histopathology findings for patients that undergo carotid endarterectomy.
Sponsors
UPECLIN HC FM Botucatu Unesp
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plaque Stiffness | Through study completion, an average of 2 years. | Measured in kilopascal (kPa). |
| Plaque Greyscale | Through study completion, an average of 2 years. | Median value of plaque histogram. |
| Plaque Instability (MRI) | Through study completion, an average of 2 years. | Degree of plaque instability as proposed by American Heart Association (I to IV). |
| Plaque Instability (Histopathology) | If patient is submitted to carotid endarterectomy. | Degree of plaque instability as proposed by American Heart Association (I to IV). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plaque Correlation with Arterial Wall | Through study completion, an average of 2 years. | Concentric or eccentric. |
| Fibrotic Cap | Through study completion, an average of 2 years. | Thin, thick or absent. |
| Echolucent Plaque Area | Through study completion, an average of 2 years. | Present or absent. |
| Peak Systolic Velocity | Through study completion, an average of 2 years. | At the site of highest velocity and turbulent flow in centimeters per second (cm/s). |
| Plaque Echogenicity | Through study completion, an average of 2 years. | Echolucent, predominantly echolucent, predominantly echogenic, echogenic or calcified. |
| Velocity Ratio | Through study completion, an average of 2 years. | At the site of highest velocity and turbulent flow compared to ipsilateral pre-stenosis common carotid artery. |
| ECST Morphological Degree of Stenosis | Through study completion, an average of 2 years. | Percentage of stenosis as measured by the European Carotid Surgery Trial (ECST) protocol (%). |
| NASCET Morphological Degree of Stenosis | Through study completion, an average of 2 years. | Percentage of stenosis as measured by the The North American Symptomatic Carotid Endarterectomy Trial (NASCET) protocol (%). |
| End Diastolic Velocity | Through study completion, an average of 2 years. | At the site of highest velocity and turbulent flow in centimeters per second (cm/s). |
| Ulceration | Through study completion, an average of 2 years. | Present or absent. |
| Plaque Surface | Through study completion, an average of 2 years. | Regular, irregular or calcified. |
| Anatomic Site of Stenosis | Through study completion, an average of 2 years. | Common carotid artery, bifurcation, internal carotid artery, external carotid artery. |
Countries
Brazil
Contacts
Primary ContactPedro L Mellucci Filho, M.D.
Backup ContactMarcone L Sobreira, Ph.D.
Outcome results
None listed