NCT05909982已完成1 期
Effect of Ischemic Post-conditioning on Infarct Volume 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 20 人开始时间: 2023年4月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Infarct volume
研究概览
简要总结
Ischemic post-conditioning is a neuroprotective strategy attenuating reperfusion injury in animal stroke models. 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. This study aims to assess the infarct volume after 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
- Na
- 干预模型
- Single Group
- 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;
- •With an occlusion of unilateral middle cerebral artery M1 segment/distal intracranial carotid artery;
- •Successful recanalization (mTICI ≥ 2b) after thrombectomy confirmed by DSA;
- •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;
- •Stenting in the middle cerebral artery M1 segment/distal intracranial carotid artery during thrombectomy;
- •> 2 times balloon dilations as rescue therapy due to angioplasty during thrombectomy;
- •Moderate/severe residual stenosis (≥ 50%) in the offending artery after 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
时间窗: 72 hours after procedure
Infarct volume at 72 hours after procedure
次要结局
- The progression of infarct volume(Baseline and 72 hours after procedure)
- The proportion of functional independence at 90 days(90 days after procedure)
- The distribution of the mRS score at 90 days(90 days after procedure)
- The proportion of early neurological improvement(24 hours after procedure)
- Recanalization rate(24 hours after procedure)
- National Institute of Health Stroke Scale (NIHSS) score(24 hours after procedure)
- The proportion of favorable outcome at 90 days(90 days after procedure)
- NIHSS score at 7 days after procedure/discharge(7 days after procedure/discharge)
- Hemodynamic assessment(Within 24 hours after procedure)
研究者
Ji Xunming,MD,PhD
Professor
Capital Medical University
研究点 (1)
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