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临床试验/NCT03104556
NCT03104556已完成不适用

Silent sTROke duriNG MitraClip Implantation - STRONG-MitraClip

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2017年4月14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
54
试验地点
1
主要终点
Total amount of high intensity signals (HITS) during the predefined procedural intervals

研究概览

简要总结

The MitraClip-procedure offers an interventional treatment for high risk patients with severe symptomatic mitral regurgitation. The number of new cerebral ischemic lesions without clinical manifestations is high. The aim of this study is to determine the frequency of cerebral embolisms and cerebral lesions during the MitraClip-procedure using transcranial doppler ultrasound and magnetic resonance imaging.

详细描述

Mitral regurgitation is the second most common manifestation of valvular heart disease in adults. Surgical reconstruction is considered treatment of choice. For some patients the surgical risk is to high an operation is refused. For those Patients the MitraClip system (Abbott Vascular, Menlo Park, CA, USA) offers a much less invasive treatment option. Occurrence of a stroke or transient ischemic attack (TIA) is one of the potential complications during this procedure. 1% of all patients have an acute stroke. The number of new ischemic lesions without clinical manifestations is much higher (up to 85%). The impact of these lesions on the global cognitive function is unclear. The aim of this study is to determine the frequency of cerebral embolisms related to predefined procedural intervals and postprocedural cerebral lesions using Transcranial Doppler ultrasound and magnetic resonance imaging. Furthermore we want to study the correlation between cerebral embolisms seen as high intensity signals in transcranial duplex ultrasound and cerebral lesions seen in the cMRT. The results should build a basis for further studies that want to reduce the amount of cerebral lesions.

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 undergoing a MitraClip-procedure due to mitral regurgitation in the study period Written consent Procedure recommended by a Cardio-Thoracic Surgery Conference

排除标准

  • Patients who are not able to give consent Patients <18 years Participation in another interventional Trial Pregnant or lactating females Contraindication to MRI

结局指标

主要结局

Total amount of high intensity signals (HITS) during the predefined procedural intervals

时间窗: during the procedure

次要结局

  • Incidence of peri- and postprocedural stroke(0-72h)
  • Incidence of delirium after MitraClip(0-72h)
  • Total amount of high intensity signals and cerebral lesions related to primary and secondary mitral regurgitation(0-72h)
  • Localizations of cerebral lesions after MitraClip-procedure(0-72h)

研究者

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

Alexander Lauten

Prof. Dr. med. A. Lauten

Charite University, Berlin, Germany

研究点 (1)

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