Silent sTROke duriNG MitraClip Implantation - STRONG-MitraClip
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
- 否
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
Alexander Lauten
Prof. Dr. med. A. Lauten
Charite University, Berlin, Germany
