Evaluation of Atherosclerotic Carotid Plaque Stiffness by Shear Wave Elastography, Greyscale Median, Magnetic Resonance Imaging and Histopathological Analysis: Diagnostic Test Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Plaque Stiffness
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with atherosclerotic carotid plaques that develop stenosis superior to 50%.
排除标准
- •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.
结局指标
主要结局
Plaque Stiffness
时间窗: Through study completion, an average of 2 years.
Measured in kilopascal (kPa).
Plaque Greyscale
时间窗: Through study completion, an average of 2 years.
Median value of plaque histogram.
Plaque Instability (MRI)
时间窗: Through study completion, an average of 2 years.
Degree of plaque instability as proposed by American Heart Association (I to IV).
Plaque Instability (Histopathology)
时间窗: If patient is submitted to carotid endarterectomy.
Degree of plaque instability as proposed by American Heart Association (I to IV).
次要结局
- Echolucent Plaque Area(Through study completion, an average of 2 years.)
- Anatomic Site of Stenosis(Through study completion, an average of 2 years.)
- Plaque Correlation with Arterial Wall(Through study completion, an average of 2 years.)
- Fibrotic Cap(Through study completion, an average of 2 years.)
- Peak Systolic Velocity(Through study completion, an average of 2 years.)
- ECST Morphological Degree of Stenosis(Through study completion, an average of 2 years.)
- End Diastolic Velocity(Through study completion, an average of 2 years.)
- Velocity Ratio(Through study completion, an average of 2 years.)
- Plaque Surface(Through study completion, an average of 2 years.)
- Plaque Echogenicity(Through study completion, an average of 2 years.)
- Ulceration(Through study completion, an average of 2 years.)
- NASCET Morphological Degree of Stenosis(Through study completion, an average of 2 years.)
研究者
Matheus Bertanha, PhD
Professor
UPECLIN HC FM Botucatu Unesp