1 Neurology Department and Stroke Centre, Centre Hospitalier de Versailles, Le Chesnay, France.
2 Université de Versailles Saint-Quentin-en-Yvelines, Versailles, France.
Int J Stroke. 2016 Oct;11(8):938-943. doi: 10.1177/1747493016660098. Epub 2016 Jul 19.
Rationale Remote ischemic per-conditioning-causing transient limb ischemia to induce ischemic tolerance in other organs-reduces final infarct size in animal stroke models. Aim To evaluate whether remote ischemic per-conditioning during acute ischemic stroke (<6 h) reduces brain infarct size at 24 h. Methods and design This study is being performed in five French hospitals using a prospective randomized open blinded end-point design. Adults with magnetic resonance imaging confirmed ischemic stroke within 6 h of symptom onset and clinical deficit of 5-25 according to National Institutes of Health Stroke Scale will be randomized 1:1 to remote ischemic per-conditioning or control (stratified by center and intravenous fibrinolysis use). Remote ischemic per-conditioning will consist of four cycles of electronic tourniquet inflation (5 min) and deflation (5 min) to a thigh within 6 h of symptom onset. Magnetic resonance imaging is repeated 24 h after stroke onset. Sample size estimates For a difference of 15 cm in brain infarct growth between groups, 200 patients will be included for 5% significance and 80% power. Study outcomes The primary outcome will be the difference in brain infarct growth from baseline to 24 h in the intervention versus control groups (by diffusion-weighted image magnetic resonance imaging). Secondary outcomes include: National Institutes of Health Stroke Scale score absolute difference between baseline and 24 h, three-month modified Rankin score and daily living activities, mortality, and tolerance and side effects of remote ischemic per-conditioning. Discussion The only remote ischemic per-conditioning trial in humans with stroke did not show remote ischemic per-conditioning to be effective. REmote iSchemic Conditioning in acUtE BRAin INfarction, which has important design differences, should provide more information on the use of this intervention in patients with acute ischemic stroke.
通过短暂性肢体缺血对每一条件进行远程缺血预处理，以诱导其他器官产生缺血耐受，从而减少动物中风模型中的最终梗死面积。目的：评估急性缺血性中风（<6 小时）期间进行远程缺血预处理是否能降低 24 小时时的脑梗死面积。方法和设计：这项研究在法国的五家医院进行，采用前瞻性随机开放盲终点设计。符合以下条件的成年人将被纳入研究：磁共振成像（MRI）证实发病 6 小时内出现缺血性中风，且美国国立卫生研究院中风量表（NIHSS）评分的临床缺损为 5-25 分。患者将被随机分为远程缺血预处理组或对照组（按中心和静脉溶栓使用分层），1:1 分配。远程缺血预处理将包括在发病 6 小时内对大腿进行 4 个周期的电子止血带充气（5 分钟）和放气（5 分钟）。中风发病后 24 小时重复进行 MRI。样本量估计：对于两组间脑梗死生长差异为 15cm，将纳入 200 例患者进行统计分析，以 5%的显著性水平和 80%的功效进行检验。研究结果：主要结果是干预组与对照组之间从基线到 24 小时脑梗死生长的差异（通过弥散加权成像 MRI 评估）。次要结果包括：NIHSS 评分基线与 24 小时的绝对差值、三个月改良 Rankin 评分和日常生活活动、死亡率以及远程缺血预处理的耐受性和副作用。讨论：唯一一项在人类中风中进行的远程缺血预处理试验并未显示远程缺血预处理有效。REmote iSchemic Conditioning in acUtE BRAin INfarction（急性脑梗死中的远程缺血预处理）具有重要的设计差异，应能提供更多关于该干预措施在急性缺血性中风患者中应用的信息。
