Remote Ischemic Conditioning for Acute Moderate Posterior Ischemic Stroke (RICAMIS2): a Prospective, Random, Open Label, Blinded End Point, Multi-center Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,600
- 试验地点
- 1
- 主要终点
- proportion of excellent outcome
研究概览
简要总结
A substantial body of basic and clinical research has demonstrated the protective effects of remote ischemic conditioning (RIC) in ischemic stroke. While these clinical studies support the safety of RIC, the neuroprotective benefits of RIC in acute ischemic stroke (AIS) patients lack robust evidence due to small sample sizes, heterogeneous RIC protocols, and variability in the severity of neurological deficits among study populations. Our recent multicenter randomized clinical trial, the RICAMIS study, investigated the efficacy of RIC in patients with acute moderate ischemic stroke. The results showed that RIC administered within 48 hours of onset significantly improved 90-day neurological outcomes in patients with moderate stroke severity. It is well established that anterior circulation stroke (ACS) and posterior circulation stroke (PCS) differ in multiple aspects, including anatomical structure, collateral circulation, blood supply, clinical manifestations, prognosis, ischemic tolerance time, and treatment response. For instance, compared to the anterior circulation, the posterior circulation has poorer collateral circulation, a higher proportion of stroke etiologies attributed to atherosclerosis, and longer ischemic tolerance time. Consequently, intravenous thrombolysis and endovascular therapy may offer a more extended therapeutic time window for PCS patients. A prespecified subgroup analysis of the RICAMIS study revealed that patients with PCS derived greater benefit from RIC than those with ACS. However, this finding requires further validation through prospective studies, as prior research has never specifically examined the efficacy of RIC in PCS patients.
Based on the above discussion, this study aims to investigate the efficacy and safety of RIC in patients with acute moderate PCS.
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
- Single (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;
- •Time from onset to treatment: ≤48 hours;
- •Posterior circulation ischemic stroke confirmed by CT or MRI, including patients who have received intravenous thrombolysis or endovascular therapy;
- •NIHSS score at randomization: 6-16, with an item 1a (level of consciousness) score of 0-1;
- •First-ever stroke or prior stroke without significant residual disability (modified Rankin Scale score ≤1);
- •Signed informed consent.
排除标准
- •intracerebral hemorrhage or subarachnoid hemorrhage；
- •Uncontrolled severe hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg despite antihypertensive therapy)；
- •Subclavian artery stenosis ≥ 50% or subclavian steal syndrome;
- •Intracranial tumor, arteriovenous malformation or aneurysm;
- •Severe abnormalities in coagulation;
- •Any contraindication for remote ischemic adaptation: the upper limb has serious soft tissue injury, fracture or vascular injury, distal upper limb perivascular lesions, etc.;
- •Participating in other clinical trials within 3 months;
- •Comorbidity with any serious diseases and life expectancy is less than half a year;
- •Patients not suitable for this clinical studies considered by researcher;
研究组 & 干预措施
control
standard stroke care
RIC group
remote ischemic conditioning, twice a day, for 10 days.
干预措施: remote ischemic conditioning (Device)
结局指标
主要结局
proportion of excellent outcome
时间窗: 90±7 days
Excellent outcome is defined as modified Rankin Scale (mRS) score of 0-1. mRS ranges from 0-6, higher scores mean a worse outcome
次要结局
- proportion of favorable outcome(90±7 days)
- Distribution of modified Rankin Scale (mRS)(90±7 days)
- change in National Institute of Health stroke scale (NIHSS)(10±2 days)
- The incidence of stroke-associated pneumonia (SAP)(10±2 days or during hospitalization, whichever is earlier.)
- death due to all causes(90±7 days)
- occurrence rate of the composite events of nonfatal stroke, nonfatal myocardial infarction, and other cardiovascular events(90±7 days)
- change in National Institute of Health stroke scale (NIHSS)(24±6 hours)
研究者
Hui-Sheng Chen
Director
General Hospital of Shenyang Military Region