Magnesium Therapy: a Novel Platform for Neuroprotectant Sampling in Acute Stroke
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 4
- 主要终点
- Magnesium concentration
研究概览
简要总结
This investigation will address the safety and feasibility of distal, intra-arterial sampling through endovascular access, in acute stroke patients. Levels of Magnesium will be measured in the region of infarct in patients who had been treated with intravenous Magnesium therapy following an acute stroke. This study attempts to address whether the traditional intravenous means of neuroprotectant administration achieves adequate concentration of the therapeutic agent in the area of diseased tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with acute cerebral ischemia due to ICA or MCA occlusion,
- •Patient already enrolled in the NIH FAST-MAG clinical trial,
- •Patient's clinical attending physician plans mechanical embolectomy procedure as part of routine clinical care.
- •Age 40-95 inclusive (age criteria for FAST-MAG Trial).
排除标准
- •Technical inability to navigate microcatheter to target clot.
- •Patient or surrogate unavailable for consent
研究组 & 干预措施
Endovascular Sampling
Paired sampling from the distal arterial(endovascular catheter) and peripheral venous (femoral sheath) locations in acute stroke patients undergoing endovascular recanalization who received intravenous Magnesium Sulfate as a part of the FAST-MAG study
干预措施: endovascular sampling (Other)
结局指标
主要结局
Magnesium concentration
时间窗: intra-procedure (at time of first pass of retrieval device)
The primary endpoint is the relative concentration of Mg in the core cerebral ischemic zone, compared to systemic therapeutic Mg levels, as a measure of delivery efficacy of systemic administration.
次要结局
- Sampling feasibility(intra-procedural (at time of first pass of retrieval device))
- Safety(post-operative day 1)
研究者
William Mack
Assistant Professor of Neurosurgery
University of Southern California