Shear Wave Elastography for Carotid Atherosclerotic Plaques

Официальное название

Evaluation of Atherosclerotic Carotid Plaque Stiffness by Shear Wave Elastography, Greyscale Median, Magnetic Resonance Imaging and Histopathological Analysis: Diagnostic Test Study

Обзор

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.

Вмешательства

• Диагностический тест Vascular Ultrasound
  Complete vascular ultrasound routine in B mode, color mode and Doppler.
• Диагностический тест Shear Wave Elastography
  Vascular ultrasound assisted shear wave elastography of the atherosclerotic plaque.
• Диагностический тест Greyscale 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.
• Диагностический тест Magnetic Resonance Imaging
  Assessment of the plaque and carotid residual lumen by magnetic resonance.
• Диагностический тест Histopathology
  Histopathology findings for patients that undergo carotid endarterectomy.

Первичные конечные точки

• Plaque Stiffness [Срок оценки: Through study completion, an average of 2 years.]
• Plaque Greyscale [Срок оценки: Through study completion, an average of 2 years.]
• Plaque Instability (MRI) [Срок оценки: Through study completion, an average of 2 years.]
• Plaque Instability (Histopathology) [Срок оценки: If patient is submitted to carotid endarterectomy.]

Вторичные конечные точки (12)

• Plaque Surface [Срок оценки: Through study completion, an average of 2 years.]
• Anatomic Site of Stenosis [Срок оценки: Through study completion, an average of 2 years.]
• Plaque Correlation with Arterial Wall [Срок оценки: Through study completion, an average of 2 years.]
• Fibrotic Cap [Срок оценки: Through study completion, an average of 2 years.]
• Echolucent Plaque Area [Срок оценки: Through study completion, an average of 2 years.]
• Plaque Echogenicity [Срок оценки: Through study completion, an average of 2 years.]
• Ulceration [Срок оценки: Through study completion, an average of 2 years.]
• Peak Systolic Velocity [Срок оценки: Through study completion, an average of 2 years.]
• End Diastolic Velocity [Срок оценки: Through study completion, an average of 2 years.]
• Velocity Ratio [Срок оценки: Through study completion, an average of 2 years.]
• ECST Morphological Degree of Stenosis [Срок оценки: Through study completion, an average of 2 years.]
• NASCET Morphological Degree of Stenosis [Срок оценки: Through study completion, an average of 2 years.]

Критерии участия

Критерии включения

• Patients with atherosclerotic carotid plaques that develop stenosis superior to 50%.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Бразилия · 1 центр

• Sao Paulo State University — Botucatu

Идентификаторы

NCT: NCT06214429 · UPECLIN-MB-7

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗