Stroke Center, Department of Neurology, The First Hospital of Jilin University, Changchun, China.
Neuroscience Research Center, The First Hospital of Jilin University, Changchun, China.
Int J Stroke. 2023 Apr;18(4):484-489. doi: 10.1177/17474930221121429. Epub 2022 Sep 12.
RATIONALE/AIM: Many patients undergoing successful recanalization after endovascular thrombectomy (EVT) do not have a good outcome; additional neuroprotection might benefit this group. Remote ischemic conditioning (RIC) stimulates endogenous protective mechanisms and may have a neuroprotective in acute brain ischemia. The safety and efficacy of RIC combined with endovascular thrombectomy (SERIC-EVT) trial is investigating the safety and efficacy of RIC for patients with acute ischemic stroke (AIS) who underwent EVT due to large vessel occlusion of the anterior circulation.
SERIC-EVT is a multicenter, randomized, parallel-controlled, and blinded endpoint clinical trial. Patients are recruited from 10 hospitals in Jilin Province, Northeast China. Patients with anterior circulation AIS undergoing EVT due to large vessel occlusion are randomized in a 1:1 ratio to RIC or sham-RIC. Participants will receive standard medical treatment and an inflation pressure of 200 mmHg (RIC group) or 60 mmHg (sham-RIC group) twice daily for seven consecutive days.
The primary outcome is the proportion of patients with modified Rankin Scale (mRS) score of 0-2 on day 90. Secondary outcome measures include the National Institute of Health Stroke Scale, Barthel Index, and mRS scores obtained at 24 h, 7 days, 30 ± 3 days, and 90 ± 3 days post-EVT, recanalization rate, expanded Thrombolysis in Cerebral Infarction score, and symptomatic intracranial hemorrhage post-EVT. Mortality and all adverse events, including skin changes and pain scores, within the first 90 days will be used as safety outcome measures.
Based on previous studies, we estimate a 14% difference in functional independence (the mRS ⩽2) between RIC and sham-RIC groups. Considering a significance level of 5% and power of 80%, and one-fifth of patients lost to follow up, the planned sample size is 498 patients (249 per group).
RIC might be a strategy that improves 3-month clinical outcomes in AIS patients who have undergone EVT due to large vessel occlusion of anterior circulation. SERIC-EVT will determine whether this is the case.
背景/目的：许多接受血管内血栓切除术（EVT）成功再通的患者预后不佳；额外的神经保护可能对这组患者有益。远程缺血预处理（RIC）可刺激内源性保护机制，并可能对急性脑缺血具有神经保护作用。RIC 联合血管内血栓切除术（SERIC-EVT）试验正在研究 RIC 对因前循环大血管闭塞而接受 EVT 的急性缺血性脑卒中（AIS）患者的安全性和有效性。
SERIC-EVT 是一项多中心、随机、平行对照、盲法终点临床试验。患者来自中国东北吉林省的 10 家医院。因前循环大血管闭塞而行 EVT 的 AIS 患者，按 1:1 比例随机分为 RIC 或假 RIC 组。参与者将接受标准药物治疗，并在连续 7 天内每天两次接受 200mmHg（RIC 组）或 60mmHg（假 RIC 组）的充气压力。
主要结局是 90 天时改良 Rankin 量表（mRS）评分 0-2 的患者比例。次要结局指标包括国立卫生研究院卒中量表（NIHSS）、巴氏指数和 EVT 后 24 小时、7 天、30±3 天和 90±3 天的 mRS 评分、再通率、扩展溶栓治疗脑梗死评分和 EVT 后症状性颅内出血。90 天内的死亡率和所有不良事件，包括皮肤改变和疼痛评分，将作为安全性结局指标。
根据既往研究，我们估计 RIC 和假 RIC 组之间功能独立性（mRS≤2）的差异为 14%。考虑到 5%的显著性水平和 80%的功效，以及五分之一的患者失访，计划的样本量为 498 例患者（每组 249 例）。
RIC 可能是一种改善因前循环大血管闭塞而行 EVT 的 AIS 患者 3 个月临床结局的策略。SERIC-EVT 将确定这是否属实。
