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动脉内选择性低温硫酸镁输注与急性缺血性中风中血管血栓切除术结合 (ICE-MAG)

2026年8月11日 更新者：Ji Xunming,MD,PhD、Capital Medical University

急性缺血性中风中选择性动脉内低温硫酸镁输注与血管内血栓切除术结合：一项1/2期随机临床试验

这项研究的主要目的是估计急性缺血性中风患者血管内血栓切除术后选择性动脉内低温硫酸镁输注的安全性和有效性

研究概览

地位

邀请报名

条件

干预/治疗

详细说明

Protocol Deviation & Planned Phase 2 Adjustment Statement The pre-specified weight-based magnesium dilution strategy could not be executed during phase 1 due to lack of on-demand intraoperative pharmacy preparation capacity for hyperacute stroke patients. All 9 phase 1 subjects received standardized cold perfusate with a fixed magnesium concentration of 20.29 mmol/L (5g MgSO₄·7H₂O diluted into 1000 mL 4℃ saline), with volumetric escalation (350/500/650 mL) only, without varying magnesium concentration. This temporary fixed-concentration regimen was a pragmatic emergency workflow compromise, not the permanent trial dosing design.

In phase 2 of this integrated registered trial, the validated safe upper limit of 650 mL total infusion volume will be fixed to avoid intracranial fluid overload. We will first conduct single-variable magnesium concentration escalation across six sequential ascending tiers:

20.29 mmol/L (5 g stock diluted in 1000 mL 0.9% saline) 22.54 mmol/L (5 g stock diluted in 900 mL 0.9% saline) 25.36 mmol/L (5 g stock diluted in 800 mL 0.9% saline) 28.98 mmol/L (5 g stock diluted in 700 mL 0.9% saline) 33.81 mmol/L (5 g stock diluted in 600 mL 0.9% saline) 40.57 mmol/L (5 g stock diluted in 500 mL 0.9% saline) After establishing a tolerable magnesium concentration threshold and identifying the maximum tolerated dose, the original registry-specified weight-individualized compounding method (Target Mg = 0.6 μmol/mL × patient body weight) will be fully applied for efficacy evaluation cohorts. This amendment was reviewed and formally approved by the institutional review board (Amendment No.XYFY2025-KL360-02).

研究类型

介入性

注册 (估计的)

42

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
    • Jiangsu
      • Xuzhou、Jiangsu、中国、221000
        • Affiliated Hospital of Xuzhou Medical University

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

纳入标准：

  1. 18-80岁的年龄范围（包括临界价值）；
  2. 没有性别限制；
  3. 临床诊断是前循环的急性缺血性中风，负责血管的急性阻塞部位位于颈内动脉内部的颅内段，以及中大脑中部动脉的M1或M2段；
  4. 症状和体征与急性前循环缺血性中风一致，NIHSS≥6；
  5. 急性缺血性中风的发作到血管内血栓切除术的时间在24小时内；
  6. 急性缺血性中风血管血栓切除术的适应症：①在发作6小时内，方面得分≥6分； ②发作后6-16小时，满足Duduse-3标准（梗塞核心体积<70 mL，不匹配率≥1.8和不匹配体积> 15 ml）或黎明标准（NIHSS≥10≥10和梗塞核心体积<31 ml）；或NIHSS≥20和梗死体积31-51 mL）； ③在发病的16-24小时内，符合黎明标准（NIHSS≥10点，梗塞核心体积<31ml）；或NIHSS≥20点和梗塞体积31-51 mL）
  7. 中风前的MRS得分为0-1分；
  8. 患者或其法律亲戚提供的书面知情同意书。

排除标准：

一般排除标准：

  1. 临床表现表明存在颅内大脑实质出血或蛛网膜下腔出血（即使成像结果正常）；
  2. 在中风期间，伴有癫痫病，无法获得准确的NIHSS分数。
  3. 伴随着昏迷或精神障碍，它可能会干扰神经功能的评估。
  4. 对碘化对比剂过敏的历史或过敏性休克史；

  5. 基线血糖<50mg/dl（2.78mmol）或> 400mg/dl（22.20mmol）;

    *可接受的指尖血糖结果

  6. 基线血小板计数<50×10^9/l;
  7. 最近（即 在纳入研究的前30天内，就有存在明显的胃肠道或其他临床意义的大量出血的病史。主动出血，异常凝血因子或出血趋势（服用具有INR≥3或Pt≥3×ULN的抗凝凝药物；如果研究人员认为受试者没有凝血功能障碍，则无需等待等待凝结测试结果即可确定是否注册）；
  8. 在中风期间，可能需要全身治疗的发烧或主动感染（例如活性肺结核）；
  9. NYHA标准> 1的慢性心力衰竭历史；不受控制的高血压（标准化治疗后的收缩压> 180mmHg或舒张压> 105mmHg），低血压（标准化治疗后的收缩压≤100mmHg），不稳定的心绞痛，心肌梗塞或旁路或旁路或旁路手术在6个月内；
  10. 伴随着肺部疾病，例如慢性阻塞性肺部疾病，结核病，肺炎，肺炎，性胸骨舒张，肺纤维化，支气管肺发育不良，胸腔肺炎，胸膜肿瘤，急性呼吸窘迫综合征，异常呼吸等；
  11. 严重的肝脏和肾功能障碍，包括但不限于：肝硬化，肝性脑病，腹水，肾衰竭或尿毒症（CCR <25ml/min），肝烯综合征等；
  12. 怀孕或哺乳的妇女；
  13. 经皮心血管和脑血管干预和大型手术后48小时内急性中风患者；
  14. 目前参与介入的临床试验并使用研究药物或医疗设备；
  15. 由于其他原因，参与者可能无法完成这项研究，或者可能没有被认为被研究人员纳入其中；

图像排除标准：

  1. CTA/MRA/DSA显示出过度的容器曲率，这可能会阻碍介入仪器的传递；
  2. 根据病史和CTA/MRA/DSA，可疑的脑血管炎；
  3. 根据病史和CTA/MRA/DSA的疑似主动脉夹层；
  4. CTA/MRA/DSA证实了多血管的区域阻塞（例如双侧前循环或前/后循环，具有颅内串联病变的颅外颈动脉），或双侧梗塞或多个区域疾病的临床证据；
  5. CTA/MRA/DSA证实Moyamoya病或Moyamoya综合征；
  6. CT/MRI证实了中线转移的显着影响；
  7. CT/MRI证实存在颅内肿瘤（不包括小脑膜瘤）；
  8. CT/MRI证实存在颅内出血。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：顺序分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
假比较器：控制
仅血管内血栓切除术
程序：血管内血栓切除术
血管内血栓切除术
实验性的：Selective intra-arterial hypothermic magnesium sulfate infusion of low volume

Endovascular thrombectomy combination with selective intra-arterial hypothermic magnesium sulfate infusion (350 ml).

Note: In phase 1, all participants in these three volume-escalation arms received a uniform fixed-concentration perfusate of 20.29 mmol/L (5 g magnesium sulfate stock diluted into 1000 mL pre-cooled saline). Weight-tailored perfusate originally specified in registry could not be implemented due to absence of emergency pharmacy fast-track compounding workflow.
程序：Endovascular thrombectomy combination with selective intra-arterial hypothermic magnesium sulfate infusion (350 ml).

According to patient's weight, magnesium sulfate (MgSO4) will be diluted to 350 ml 4°C saline solution (0.6μmol/kg/ml). During the thrombectomy procedure, a micro-catheter will be advanced until it reaches beyond the clot responsible for the ischemic symptoms, then cold 50 ml MgSO4 solution will be infused into the ischemic territory at 10 ml/min through the micro-catheter. After that, thrombectomy with a stent retriever will be performed to recanalize the occluded vessel as soon as possible. Immediately after successful thrombectomy, cold MgSO4 solution will be re-infused into the ischemic brain tissue through the catheter at a rate of 30 ml/min for 10 min.

Note: The pre-planned weight-tailored magnesium solution could not be prepared intraoperatively in phase 1 due to unavailable emergency pharmacy workflow. All 9 patients received uniform 20.29 mmol/L perfusate, with only infusion volume escalated.
实验性的：Selective intra-arterial hypothermic magnesium sulfate infusion of moderate volume

Endovascular thrombectomy combination with selective intra-arterial hypothermic magnesium sulfate infusion (500 ml).

Note: In phase 1, all participants in these three volume-escalation arms received a uniform fixed-concentration perfusate of 20.29 mmol/L (5 g magnesium sulfate stock diluted into 1000 mL pre-cooled saline). Weight-tailored perfusate originally specified in registry could not be implemented due to absence of emergency pharmacy fast-track compounding workflow.
程序：Endovascular thrombectomy combination with selective intra-arterial hypothermic magnesium sulfate infusion (500 ml).
According to patient's weight, magnesium sulfate (MgSO4) will be diluted to 500 ml 4°C saline solution (0.6μmol/kg/ml). During the thrombectomy procedure, a micro-catheter will be advanced until it reaches beyond the clot responsible for the ischemic symptoms, then cold 50 ml MgSO4 solution will be infused into the ischemic territory at 10 ml/min through the micro-catheter. After that, thrombectomy with a stent retriever will be performed to recanalize the occluded vessel as soon as possible. Immediately after successful thrombectomy, cold MgSO4 solution will be re-infused into the ischemic brain tissue through the catheter at a rate of 30 ml/min for 10 min. Then pause for 5 min, followed by another 5 min of infusion at the original rate.Note: The pre-planned weight-tailored magnesium solution could not be prepared intraoperatively in phase 1 due to unavailable emergency pharmacy workflow. All 9 patients received uniform 20.29 mmol/L perfusate, with only infusion volume escalated.
实验性的：Selective intra-arterial hypothermic magnesium sulfate infusion of high volumn

Endovascular thrombectomy combination with selective intra-arterial hypothermic magnesium sulfate infusion (650 ml).

Note: In phase 1, all participants in these three volume-escalation arms received a uniform fixed-concentration perfusate of 20.29 mmol/L (5 g magnesium sulfate stock diluted into 1000 mL pre-cooled saline). Weight-tailored perfusate originally specified in registry could not be implemented due to absence of emergency pharmacy fast-track compounding workflow.
程序：Endovascular thrombectomy combination with selective intra-arterial hypothermic magnesium sulfate infusion (650 ml).
According to patient's weight, magnesium sulfate (MgSO4) will be diluted to 650 ml 4°C saline solution (0.6μmol/kg/ml). During the thrombectomy procedure, a micro-catheter will be advanced until it reaches beyond the clot responsible for the ischemic symptoms, then cold 50 ml MgSO4 solution will be infused into the ischemic territory at 10 ml/min through the micro-catheter. After that, thrombectomy with a stent retriever will be performed to recanalize the occluded vessel as soon as possible. Immediately after successful thrombectomy, cold MgSO4 solution will be re-infused into the ischemic brain tissue through the catheter at a rate of 30 ml/min for 10 min. Then pause for 5 min, followed by intermittent infusion at the original rate for another 5 min twice. The interval between two times is also 5 min.Note: The pre-planned weight-tailored magnesium solution could not be prepared intraoperatively in phase 1.All 9 patients received uniform 20.29 mmol/L perfusate.
实验性的：Phase 2 Fixed-Volume Concentration-Escalation Cohort
Intra-arterial selective cooling magnesium sulfate perfusate. All subjects receive a fixed maximum total infusion volume of 650 mL. Six ascending magnesium concentration tiers will be tested sequentially: 20.29 mmol/L, 22.54 mmol/L, 25.36 mmol/L, 28.98 mmol/L, 33.81 mmol/L, and 40.57 mmol/L. Each concentration is prepared by diluting one 5 g/10 mL magnesium sulfate heptahydrate stock vial into 1000 mL, 900 mL, 800 mL, 700 mL, 600 mL, or 500 mL pre-cooled 4 °C normal saline, respectively. After identifying the maximum tolerated magnesium concentration, the original registry-specified weight-individualized compounding formula will be implemented for subsequent efficacy-focused cohorts. This phase is not yet enrolling participants.
程序：Phase 2 Fixed-Volume Concentration-Escalation Cohort
This unenrolled phase 2 cohort uses a fixed 650 mL maximum infusion volume with six ascending magnesium concentrations: 20.29, 22.54, 25.36, 28.98, 33.81, 40.57 mmol/L. Each tier is mixed by diluting one 5 g magnesium stock into 1000/900/800/700/600/500 mL pre-cooled saline. After confirming safe magnesium levels, we will adopt the registry's weight-based formulation. Infusion protocols match phase 1, and this two-stage design is approved under IRB amendment No.XYFY2025-KL360-02

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
90 天死亡率
大体时间：动脉内低温硫酸镁输注后 90 天
动脉内低温硫酸镁输注后 90 天
有效评估指标：
大体时间：动脉内低温硫酸镁输注后90天
具有90天功能独立性的受试者百分比（定义为MRS 0-2）（％）评估时间：90 d（±14 d）
动脉内低温硫酸镁输注后90天

次要结果测量

结果测量
措施说明
大体时间
与治疗期间发生的干预相关的 3-5 级治疗紧急不良事件 (TEAE)
大体时间：动脉内低温硫酸镁输注后72小时内
TEAE包括但不限于心血管系统反应、心电图异常、水电解质失衡、核心温度降低、血管痉挛、寒战、感染、意识障碍。
动脉内低温硫酸镁输注后72小时内
所有与治疗期间发生的干预相关的治疗紧急不良事件 (TEAE)
大体时间：动脉内低温硫酸镁输注后72小时内
动脉内低温硫酸镁输注后72小时内
所有治疗期间发生的治疗紧急不良事件 (TEAE)
大体时间：动脉内低温硫酸镁输注后72小时内
动脉内低温硫酸镁输注后72小时内
有症状/无症状的颅内出血的比例在24小时内
大体时间：动脉内低温硫酸镁输注后24小时内
动脉内低温硫酸镁输注后24小时内
No reflow rate
大体时间：24 hours (±6 hours) after surgery
No reflow rate, defined as the percentage of subjects with a decrease in CBV or CBF by more than 15% compared to the contralateral side at 24 hours after treatment (%)
24 hours (±6 hours) after surgery
Cerebrospinal fluid parameters
大体时间：24 hours-7 day
The levels of Mg²⁺, glutamate, NFL, MMP-9, inflammatory factors, as well as the metabolomics/proteomics of cerebrospinal fluid, are used to verify the central nervous system protection mechanism
24 hours-7 day

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Capital Medical University

合作者

The Affiliated Hospital of Xuzhou Medical University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年9月15日

初级完成 (估计的)

2026年12月30日

研究完成 (估计的)

2027年3月30日

研究注册日期

首次提交

2025年8月27日

首先提交符合 QC 标准的

2025年9月1日

首次发布 (实际的)

2025年9月9日

研究记录更新

最后更新发布 (实际的)

2026年8月13日

上次提交的符合 QC 标准的更新

2026年8月11日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ICE-MAG

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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