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临床试验/NCT05785598
NCT05785598已完成不适用

Study of Perforating Arteries Detection by Ultrasound Localization Microscopy (ULM) With a Commercial Conventional Ultrasound Scanner

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年3月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
To compare the number of perforating arteries detected by ULM with the number of perforating arteries detected on TOF MRI.

研究概览

简要总结

Transcranial Doppler ultrasonography with injection of contrast agent (intravenously to enhance the ultrasound signal) is a non-invasive technique that has been used for years to study intracranial vessels that constitute the polygon of Willis. However, this technique does not allow good visualization of small vessels, such as perforating arteries.

Ultrasound localization microscopy (ULM) is based on the principle of localizing injected microbubbles in order to follow their movement to map the microvascular structure. The concentration of these microbubbles must remain low (in contrast to its classical use in Doppler ultrasound) in order to isolate and localize them. By using the same images as those performed in clinical routine by Doppler ultrasound and by processing the data offline, ULM would increase the resolution by a factor of 10 allowing potential observation of perforating arteries.

详细描述

Transcranial Doppler Ultrasound (TDI) is a non-invasive technique to study the arteries of the polygon of Willis. Nevertheless, its resolution does not allow visualization of perforating arteries. Despite the use of a contrast agent that improves the quality of the signal, perforating arteries are not detectable with the usual techniques because of their small size.

In recent years, a more powerful ultrasound technique, ultrasound localization microscopy (ULM), has been described. This technique uses conventional contrast agents and allows for vascular mapping with up to 10-fold higher resolution than with a conventional ultrasound method. It is based on the principle of localizing injected and isolated microbubbles in order to track their movement back to the microvascular structure. Recently, these techniques have been transferred to the clinical field. One of the recent applications, is 2D transcranial imaging which has allowed the observation of, among other things, an intracranial aneurysm using a research ultrasound scanner.

The objective of this project is to apply this technique on routine clinical EDTC images to visualize perforating arteries in patients with ischemic stroke (in the absence of middle cerebral artery occlusion and lacunar disease) and in subjects with Moya-Moya syndrome using a 2D clinical ultrasound scanner.

- Description of the study population and rationale for its selection

In patients with ischemic stroke, visualization of the intracranial arteries can be performed by Magnetic Resonance Imaging (MRI) Time of Flight (TOF) sequence or by transcranial Doppler ultrasound (EDTC) with the help of Sonovue contrast medium. These techniques are performed as part of routine patient care and allow visualization of the arteries of the polygon of Willis (anterior, middle and posterior cerebral arteries as well as the anterior communicating artery and posterior communicating arteries). Nevertheless, the perforating arteries are small arteries (0.34 mm) that are difficult to visualize by standard MRI and EDTC imaging with the injection of contrast: the exploration of these arteries is therefore complicated by the techniques available.

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

入选标准

  • Patients with ischemic stroke hospitalized in the neurology department of the Bichat Hospital in the absence of middle cerebral artery occlusion or lacunar disease.
  • Patients followed in the neurology department of the Bichat/Lariboisière hospital with a diagnosis of Moya-Moya disease or syndrome
  • Patient who has had a TST with contrast injection as part of his follow-up
  • Patient who has had an MRI as part of his follow-up
  • Presence of a temporal window that allows ultrasound insonification of the polygon circle of Willis.
  • Age over 18 years.
  • Patient not objecting to the analysis of their data

排除标准

  • Patient not affiliated to French Social Security.
  • Patient under guardianship or curatorship.
  • Pregnant or breastfeeding patients

结局指标

主要结局

To compare the number of perforating arteries detected by ULM with the number of perforating arteries detected on TOF MRI.

时间窗: During the ULM analyse

density of perforating arteries that start from the middle cerebral artery. The unit of measurement will be a count of bubbles tracked by ULM in each pixel of the image.

次要结局

  • To compare the number of perforating arteries detected by ULM with the number of perforating arteries detected by arteriography in the detection of perforating arteries in patients with Moya Moya disease or syndrome.(During the ULM analyse)
  • To compare the number of perforating arteries detected by ULM with the number of perforating arteries detected by the standard EDTC.(During the ULM analyse)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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