Safety and Efficacy of Remote Ischemic Conditioning for Acute Ischemic Stroke: A Multicenter, Randomized, Parallel-controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,210
- 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 acute ischemic stroke.
详细描述
In this study, 2210 cases of ischemic stroke in 72 hours were 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 in treating acute ischemic stroke.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •1) Age≥18 years, regardless of sex.
- •2) Patients with clinically definite diagnosis of acute ischemic stroke and able to commence RIC treatment within 72 hours of stroke onset.
- •3) Baseline NIHSS ≥ 4, ≤
- •4) Baseline mRS ≤ 2;
- •5) Signed and dated informed consent is obtained.
排除标准
- •1) Patients who undergo thrombolytic therapy or endovascular treatment.
- •2) The patients who had the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture, or vascular injury in the upper limb. Acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc.
- •3) Other intracranial lesions, such as cerebrovascular malformation cerebral venous diseases, tumors,s and other diseases involving the brain.
- •4) Pregnant or lactating women.
- •5) Previous remote ischemic conditioning therapy or similar treatment.
- •6) Severe hepatic and renal dysfunction.
- •7) Patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons.
- •8) Unwilling to be followed up or treated for poor compliance.
- •9) He/She is participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to admission.
- •10) Other conditions that the researchers think are not suitable for the group.
研究组 & 干预措施
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 consecutive days. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014.
干预措施: Remote ischemic conditioning (Procedure)
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 consecutive days. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014.
干预措施: Sham 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 7 days, 30±3 days, 90±3 days from onset.(7days, 30±3 days, 90±3 days)
- modified Rankin Scale (mRS) Score at 7 days, 30±3 days, 90±3 days from onset.(7days, 30±3 days, 90±3 days)
- Barthel Index (BI) at 7 days, 30±3 days, 90±3 days from onset.(7days, 30±3 days, 90±3 days)
- Proportion of patients with hemorrhagic transformation during hospitalization.(7 days)
- Frequency of adverse events during follow-up.(90 days)
研究者
Yi Yang
Associated Dean of First Hospital of Jilin University
The First Hospital of Jilin University