Intra-arterial Magnesium Therapy: A Novel Platorm for Neuroprotectant Delivery in Acute Stroke
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Magnesium Concentration in Region of Cerebral Ischemia
研究概览
简要总结
Stroke is the second leading cause of death and the leading cause of adult disability worldwide. This investigation will address the safety and feasibility of directed, intra-arterial Magnesium measurement and therapy, through endovascular access, in acute stroke patients. The proposal represents the first study to directly quantify levels of a systemically administered neuroprotectant in the region of cerebral ischemia. It also establishes a novel endovascular platform for direct delivery of neuroprotective agents to ischemic cerebral tissue distal to an occlusive thrombus. This research seeks to improve patient care by establishing a novel delivery mechanism for the rescue of threatened brain parenchyma that can be administered rapidly following acute stroke. If successful, this selective distribution will allow delivery to "at risk" tissue in a rapid manner. Salvage of viable, but threatened, penumbral tissue could afford stroke patients an increased probability of favorable long term outcome. The investigators hypothesize that endovascular, intra-arterial, Magnesium administration will deliver high concentration of this neuroprotective agent to otherwise inaccessible cerebral territories, while limiting systemic concentrations. The proposed investigation will evaluate the safety and feasibility of this novel treatment technique
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 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's clinical attending physician plans mechanical embolectomy procedure as part of routine clinical care.
排除标准
- •Severe renal impairment with creatinine 3.0 or higher,
- •Myasthenia gravis,
- •Second or third degree heart block without a pacemaker in place,
- •Technical inability to navigate microcatheter to target clot,
- •Patient already enrolled in another experimental treatment trial. Exclusion criteria 1-3 are all contraindications to magnesium therapy.
研究组 & 干预措施
Regional Intra-arterial Magnesium 0.75g
Regional Intra-arterial magnesium only 0.75 mg Magnesium Sulfate (50% Total Dose): 5 patients
干预措施: Magnesium Sulfate (Drug)
Regional Intra-arterial magnesium 1.5g
Regional Intra-arterial magnesium Sulfate Only 1.5g (100% TD): 5 patients
干预措施: Magnesium Sulfate (Drug)
Regional/ Distal (75/25%) Magnesium 1.5g
Regional/ Distal intra-arterial magnesium (75% TD regional- 1.125g / 25% distal-0.375g): 5 patients
干预措施: Magnesium Sulfate (Drug)
Regional/ Distal (50/50%) Magnesium 1.5g
Regional/ Distal intra-arterial magnesium (50% TD regional- 0.75g/ 50% distal-0.75g): 5 patients
干预措施: Magnesium Sulfate (Drug)
结局指标
主要结局
Magnesium Concentration in Region of Cerebral Ischemia
时间窗: Mg level: 1) Peripheral: Baseline and post-treatment (averaged); 2) Distal: after first pass of the clot retriever
Peripheral Magnesium Levels, meq/L will be obtained through the femoral sheath at the beginning (baseline) and end (post-treatment) of each case. These will be averaged to obtain a femoral Magnesium level. Magnesium levels distal to the occlusion will be measured at the first pass of the clot retrieving device.
次要结局
- Number of Participants With Procedure Related Serious Adverse Event(intraprocedure, postoperative day 1, 1 month, 3 month)
研究者
William Mack
Assistant Professor of Neurosurgery
University of Southern California
