Effectiveness and Biological Mechanism of Direct Ischemic Post-conditioning for Acute Stroke Patients Due to Large Vessel Occlusion: A Randomized Controlled Pilot Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Final Infarct volume
研究概览
简要总结
The goal of this clinical trial is to determine if direct ischemic post-conditioning (IPostC) can alleviate ischemic-reperfusion injury (I/R) in patients who have undergone endovascular thrombectomy (EVT). Additionally, the study aims to explore the underlying mechanisms of direct IPostC.
The primary questions this trial seeks to answer are:
- Is direct IPostC effective for acute stroke patients with large vessel occlusion?
- What are the underlying mechanisms of direct IPostC?
Participants will be randomly assigned to one of two groups: an EVT alone group or an EVT plus direct IPostC group. Direct IPostC will be administered immediately after EVT through four cycles of mechanical interruptions of reperfusion. We will evaluate outcomes based on final infarct volume, infarct volume growth, clinical parameters, and I/R-related imaging and laboratory biomarkers. Additionally, an exploratory multi-omics analysis will be conducted to uncover the detailed mechanisms of direct IPostC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ischemic stroke confirmed by CT or MRI.
- •Large vessel occlusion confirmed by CTA or MRA, including the intracranial internal
- •carotid artery (ICA) and middle cerebral artery (MCA M1/M2).
- •4. Recanalization of the occluded vessel at eTICI grade 2b/3, confirmed by DSA after thrombectomy.
- •5. The patient or legally authorized representative has signed an informed consent form.
排除标准
- •Inability to perform an MRI or CT scan for any reason.
- •Presence of any condition that would interfere with neurological assessment or any psychiatric disorders.
- •Stroke onset accompanied by seizures, resulting in the inability to obtain an accurate NIHSS baseline.
- •Presence of other serious, advanced, or terminal illnesses.
结局指标
主要结局
Final Infarct volume
时间窗: 24(-6/+12) hours after procedure
Infarct volume at 24 (-6/+12) hours postoperatively
Infarct Volume Growth
时间窗: 24(-6/+12) hours after procedure
Infarct volume at 24 (-6/+12) hours - Infarct volume at baseline; Infarct volume at 24 (-6/+12) hours - Infarct volume at 2 hours
次要结局
- Change in NIHSS between baseline and 2 hours(2 hours after procedure)
- Change in NIHSS between baseline and 24 hours(24 hours after procedure)
- Functional Independence at 90 days(90 days after randomization)
- Blood brain barrier permeability at 72 hours(72 hours after procedure)
- Functional Independence at 5 days or discharge(5 days or at discharge after randomization)
研究者
Ming Wei
Chief Physician
Tianjin Huanhu Hospital