NCT05789823招募中2 期
Efficacy and Safety of Ischemic Post-conditioning in Patients with Acute Ischemic Stroke After Mechanical Thrombectomy
Capital Medical University1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2023年11月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Infarct volume at 24 hours
研究概览
简要总结
Ischemic post-conditioning is a neuroprotective strategy that has been proven to attenuate reperfusion injury in animal models of stroke. The investigators have conducted a 3 + 3 dose-escalation trial to demonstrate the safety and tolerability of ischemic post-conditioning incrementally for a longer duration of up to 5 min × 4 cycles in stroke patients undergoing mechanical thrombectomy. The purpose of this study is to further determine the efficacy and safety of ischemic post-conditioning in patients with acute ischemic stroke who are treated with mechanical thrombectomy.
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
- 否
入选标准
- •Age ≥ 18 years;
- •Acute ischemic stroke within 24 hours from stroke onset (or from time last known well) to groin puncture;
- •Previous mRS ≤ 2;
- •Baseline NIHSS ≥ 6;
- •Baseline ASPECTS ≥ 6;
- •Unilateral middle cerebral artery occlusion with or without ipsilateral internal carotid artery occlusion;
- •Successful recanalization after mechanical thrombectomy (eTICI 2b-3);
- •Written informed consent provided by the patients or their legal relatives.
排除标准
- •Confirmed or clinically suspected cerebral vasculitis/fibromuscular dysplasia;
- •Difficulty in reaching the designated position of the balloon used for ischemic post-conditioning;
- •Complications related to thrombectomy, such as contrast agent extravasation, vascular perforation/rupture, dissection, and escape of thrombus;
- •Stenting in the middle cerebral artery M1 segment/distal intracranial carotid artery during thrombectomy;
- •> 2 times of balloon dilations as rescue therapy due to angioplasty during thrombectomy;
- •Patients with contraindications to MRI;
- •Other conditions that the investigator considered inappropriate for inclusion.
结局指标
主要结局
Infarct volume at 24 hours
时间窗: 24 hours after randomization
Infarct volume on MRI-DWI at 24 hours after randomization
次要结局
- Progression of infarct volume between baseline and 24 hours(Baseline and 24 hours after randomization)
- Progression of perfusion defect from baseline to 24 hours(Baseline and 24 hours after randomization)
- Progression of infarct volume between 2 hours and 24 hours(2 hours after randomization and 24 hours after randomization)
- Infarct volume at 5 days/at discharge(5 days after randomization or at discharge)
- The proportion of functional independence at 90 days(90 days after randomization)
- The proportion of favorable outcome at 90 days(90 days after randomization)
- The distribution of mRS score at 90 days(90 days after randomization)
- National Institute of Health Stroke Scale (NIHSS) score at 24 hours(24 hours after randomization)
- The proportion of early neurological improvement(Baseline and 24 hours after randomization)
- National Institute of Health Stroke Scale (NIHSS) score at 5 days/at discharge(5 days after randomization or at discharge)
- Recanalization rate at 24 hours(24 hours after randomization)
- Cerebral blood flow velocity of the culprit middle cerebral artery at 24 hours after randomization.(24 hours after randomization)
研究者
Ji Xunming,MD,PhD
Professor
Capital Medical University
研究点 (1)
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