Safety and Efficacy Study of Remote Ischemic Conditioning Combined With Endovascular Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion of Anterior Circulation: A Multicenter, Randomized, Parallel-controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 498
- 试验地点
- 1
- 主要终点
- Proportion of patients with modified Rankin Scale (mRS) Score 0-2
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning for patients of acute ischemic stroke who underwent endovascular thrombectomy due to large vessel occlusion of anterior circulation.
详细描述
In this study, 498 cases of ischemic stroke who undergo endovascular thrombectomy within 24 hours from the onset are included in 10 centers in China according to the principle of random, and parallel control. The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times per day for 7 consecutive days. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times per day for 7 consecutive days. Two groups will be followed up for 90 days to evaluate the efficacy and safety of remote ischemic conditioning for patients of acute ischemic stroke who underwent endovascular thrombectomy due to large vessel occlusion of anterior circulation.
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
- Double (Participant, Outcomes Assessor)
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, male or female
- •Diagnosis of acute ischemic stroke within 24 hours of symptom onset and underwent endovascular thrombectomy (EVT) adhering to current guidelines for large vessel occlusion in the anterior circulation (confirmed by computed tomography angiography or digital subtraction angiography)
- •Pre-EVT NIHSS ≥ 6
- •Premorbid mRS ≤ 2
- •Written informed consent obtained from the patient or legally responsible person
排除标准
- •Contraindication of endovascular thrombectomy
- •Contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture, or vascular injury in the upper limb, acute or subacute venous thrombosis, arterial occlusive disease, and subclavian steal syndrome
- •Head CT showing cerebral hernia and midline displacement
- •Pregnancy or lactation
- •Previous remote ischemic conditioning therapy or similar treatment
- •Severe hepatic and renal dysfunction
- •Life expectancy of less than 3 months or inability to complete the study for other reasons
- •Unwilling to be followed up or poor compliance
- •Current or past participation in other clinical research, or participation in this study within 3 months prior to admission
- •Other conditions that the researchers think make the patient unsuitable for the study
研究组 & 干预措施
Sham RIC+Standard medical treatment
Sham RIC+Standard medical treatment Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice daily for 7 days after endovascular thrombectomy. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2018.
干预措施: Sham remote ischemic conditioning (Procedure)
RIC+Standard medical treatment
RIC+Standard medical treatment Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 days after endovascular thrombectomy. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2018.
干预措施: Remote ischemic conditioning (Procedure)
结局指标
主要结局
Proportion of patients with modified Rankin Scale (mRS) Score 0-2
时间窗: 3 months
Proportion of patients with modified Rankin Scale (mRS) Score 0-2. Ranged from 0 to 6, a low value represents a better outcome.
次要结局
- National Institute of Health stroke scale (NIHSS) at 24 hours, 7 days (or discharge) after EVT.(24 hours, 7 days (or discharge))
- Barthel Index (BI) at 24 hours, 7 days (or discharge) after EVT.(24 hours, 7 days (or discharge))
- Proportion of patients with modified Rankin Scale (mRS) 0-1(90±3 days)
- modified Rankin Scale (mRS) score distribution(90±3 days)
- Recanalization rate within 7 days after EVT(7 days)
- Early neurological deterioration at 7 days(7 days)
- Frequency of Hemorrhagic transformation within 7 days(7 days)
- Frequency of symptomatic intracranial hemorrhage within 7 days(7 days)
- Death within 90 days(90±3 days)
- Frequency of adverse events within 90 days(90±3 days)
- Adverse events associated with remote ischemic conditioning within 90 days(90±3 days)
- Frequency of serious adverse events within 90 days(90±3 days)
研究者
Yi Yang
Associated Dean of First Hospital of Jilin University
The First Hospital of Jilin University