Evaluation of the Carotid Plaque Stability by Ultrafast-ultrasound Imaging (UF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- local stiffness measurement
研究概览
简要总结
Unstable plaques are characterized by lower segmental stiffness and intimal neovascularization compared to stable plaques. Our objective is to determine the capacity of the elastographic parameters obtained by the UF to discriminate the unstable to the stable plaques. We hope to improve the stroke prediction in asymptomatic patients with carotid stenosis.
详细描述
Context
Stroke is the second leading cause of death in the Western world and the leading cause of major disability in the long term. About 15% of strokes are secondary to thrombosis or embolization of an unstable atherosclerotic plaque of the carotid bifurcation. In these symptomatic patients, the degree of carotid stenosis is correlated with the risk of early recurrence. In patients with stenosis (NASCET)> 70%, endarterectomy is an intervention aimed at removing the carotid plaque to prevent stroke. In asymptomatic patients, the degree of stenosis is a limited predictive factor and a better risk stratification is required to assess the degree of the plaque vulnerability. The therapeutic decision towards endarterectomy in addition to drug therapy is debated because of a variable benefit/ risk balance. Several imaging parameters were studied: anfractuosity, heterogeneity, and vascularization of the plaque for example, without allowing a modification of the current recommendations. Our objective is to improve the evaluation of the risk of stroke by the fine characterization of the carotid stenosis to help the medical decision. We want to evaluate a new ultrasound imaging technology called Ultrafast ultrasound imaging (UF). Ultrasound has the advantage of being a non-irradiating, low-cost easily accessible.
Hypotheses
Unstable plaques are characterized by lower segmental stiffness and intimal neovascularization compared to stable plaques. Our objective is to determine the capacity of the elastographic parameters obtained by the UF to discriminate the unstable to the stable plaques. We hope to improve the stroke prediction in asymptomatic patients with carotid stenosis.
Innovative aspects
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Adults over 18 years, referred to H.E.G.P for carotid endarterectomy,
- •beneficiaries of a social security scheme,
- •having received research information and signed the consent form.
排除标准
- •Non-atherosclerotic carotid stenosis (post-radiation stenosis)
- •No social security coverage
结局指标
主要结局
local stiffness measurement
时间窗: the day of enrollment
demonstrate a significant difference in the local stiffness measurement using UF between the stable and unstable plaques, according to the histological criteria.
次要结局
- correlation between the plaque's stiffness and the histological quantification of the fibrous tissue.(at the end of the study (5 months))
- the quantification of the wall shear stress evaluated by UF Doppler between stable and unstable plaque.(the day of enrollment)
- compare all the different parameters used to evaluated the plaque's stability, but depending on whether or not the carotid stenosis is symptomatic(the day of enrollment)
- stiffness between plaque and its adjacent arterial segments(The day of enrollment.)
- correlation between the elasticity of the plaque and the histological quantification of the calcifications(The quantification of the fibrous tissue is carried out in a semi-quantitative manner by a suitable scale, which will be filled in the histological analysis)
- the quantification of vascularization by UF Doppler with the number of neovessels histologically quantified(the day of enrollment)