TransCranial Doppler for REDUCtion of Silent strokE During MitraClip Implantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- stroke volume
研究概览
简要总结
The primary goal of the TCD-REDUCE study is to demonstrate the effectiveness of continuous transcranial Doppler sonography ("sonolysis") on the reduction of the ischemic stroke volume during MitraClip implantation.
详细描述
Cardiac procedures are associated with new cerebral ischemic lesions detected on diffusion-weighted MRI (Bendszus et al., 2006).
A previous study suggests that sonolysis (continuous transcranial Doppler sonography using a 2-MHz diagnostic probe) can reduce the risk of new cerebral ischemic lesions during carotid endarterectomy and carotid angioplasty / stenting (Skoloudik et al., 2015).
Currently, it is unknown whether sonolysis can also reduce the risk of new cerebral ischemic lesions during MitraClip implantation - a percutaneous treatment option in patients with moderate / severe mitral regurgitation.
In this study, patients will receive cerebral MRI and clinical neurological / neuropsychological examination before and after MitraClip implantation. During MitraClip implantation, all patients will receive continuous transcranial Doppler sonography using a 2-MHz diagnostic probe with maximal diagnostic energy administered through either the left or the right transtemporal window (computer-generated 1:1 randomization).
The primary endpoint is the median ischemic lesion volume detected on diffusion-weighted MRI after MitraClip implantation in the sonolysis group and in the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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 with mitral regurgitation that are assigned to the MitraClip implantation by an interdisciplinary heart team according to current guidelines.
排除标准
- •contraindication to MRI examination (e.g. pace-maker, implanted metal material, claustrophobia)
- •pregnancy
- •unable to consent
- •no transtemporal window
结局指标
主要结局
stroke volume
时间窗: 0-5 days after the MitraClip Implantation
median volume (in ml) of new ischemic lesions detected on diffusion-weighted MRI after MitraClip implantation in the sonolysis and in the control group
次要结局
- cognitive outcome during hospital stay(0-5 days after the MitraClip Implantation)
- diffusion-weighted MRI lesions(0-5 days after the MitraClip Implantation)
- intracerebral hemorrhage (ICH) and / or subarachnoid hemorrhage (SAH)(0-5 days after the MitraClip Implantation)
- clinically overt stroke((1) 0-5 days after the MitraClip Implantation and (2) 3 months after MitraClip implantation)
- functional outcome((1) 0-5 days after the MitraClip Implantation and (2) 3 months after MitraClip implantation)
- cognitive outcome at follow-up(3 months after MitraClip implantation)
- delirium(0-5 days after the MitraClip Implantation)
- mortality(up to 3 months after MitraClip implantation)
- length of hospital stay (duration of hospitalization for the MitraClip implantation)(length of hospital stay (up to 3 months after MitraClip implantation))
- cerebral microbleeds (CMB)(0-5 days after the MitraClip Implantation)
研究者
Christian Nolte
Prof. Dr. Christian H. Nolte
Charite University, Berlin, Germany