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临床试验/NCT03802760
NCT03802760已完成不适用

Cerebral Microembolism in Interventional Cardiology Procedures

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年10月24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
50
试验地点
1
主要终点
Quality of cerebral microemboli (solid vs. gaseous)

研究概览

简要总结

During different interventional cardiology procedures we aim to identify cerebral microemboli load. Further we aim to differentiate the quality and the quantity of cerebral microemboli.We will measure cerebral microemboli in different interventional phases, e.g. during valve deployment, rapid pacing, post-implantation.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years
  • Interventional cardiology procedure (TAVI, MitraClip, TricuspidalClip)

排除标准

  • Allergy to ultrasound gel or materials contained in the TCD probe
  • Missing temporal bone window

结局指标

主要结局

Quality of cerebral microemboli (solid vs. gaseous)

时间窗: intraoperative phase, expected to be approx. 4 hours

The quality of cerebral microemboli is measured by Doppler ultrasonography which automatically detects and analyses the Doppler signal coming from the middle cerebral artery. According to the strength of signal reflection, the signal will be qualified as solid or gaseous.

次要结局

  • Quantity of cerebral microemboli load(intraoperative phase, expected to be approx. 4 hours)
  • Cerebral hemispheric differences (left vs. right)(intraoperative phase, expected to be approx. 4 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gabor Erdös

Principal Investigator

Insel Gruppe AG, University Hospital Bern

研究点 (1)

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