Background and Aim: Remote ischemic conditioning is a procedure purported to reduce the ischemic injury of an organ. This study aimed to explore the efficiency and safety of remote ischemic conditioning in patients with acute ischemic stroke. We hypothesized that remote ischemic conditioning administered from the first day of hospital admission would improve the infarct volume and clinical outcome at 180 days. Material and Methods: We performed a unicentric double-blind randomized controlled trial. We included all patients consecutively admitted to an Emergency Neurology Department with acute ischemic stroke, ineligible for reperfusion treatment, up to 24 hours from onset. All subjects were assigned to receive secondary stroke prevention treatment along with remote ischemic conditioning on the non-paretic upper limb during the first 5 days of hospitalization, twice daily - a blood pressure cuff placed around the arm was inflated to 20 mmHg above the systolic blood pressure (up to 180 mmHg) in the experimental group and 30 mmHg in the sham group. The primary outcome was the difference in infarct volume (measured on brain CT scan) at 180 days compared to baseline, whereas the secondary outcomes included differences in clinical scores (NIHSS, mRS, IADL, ADL) and cognitive/mood changes (MoCA, PHQ-9) at 180 days compared to baseline. Results: We enrolled 40 patients; the mean age was 65 years and 60% were men. Subjects in the interventional group had slightly better recovery in terms of disability, as demonstrated by the differences in disability scores between admission and 6 months (e.g., the median difference score for Barthel was -10 in the sham group and -17.5 in the interventional group, for ADL -2 in the sham group and -2.5 in the interventional group), as well as cognitive performance (the median difference score for MoCA was -2 in the sham group and -3 in the interventional group), but none of these differences reached statistical significance. The severity of symptoms (median difference score for NIHSS = 5 for both groups) and depression rate (median difference score for PHQ-9 = 0 for both groups) were similar in the two groups. The median difference between baseline infarct volume and final infarct volume at 6 months was slightly larger in the sham group compared to the interventional group (p = 0.4), probably due to an initial larger infarct volume in the former. Conclusion: Our results suggest that remote ischemic conditioning might improve disability and cognition. The difference between baseline infarct volume and final infarct volume at 180 days was slightly larger in the sham group.

中文翻译：

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远程缺血调节可改善急性缺血性中风后的残疾和认知：一项试点随机临床试验。

背景和目的：远程缺血调节是一种旨在减少器官缺血损伤的程序。本研究旨在探讨远程缺血调理治疗急性缺血性脑卒中患者的有效性和安全性。我们假设从入院第一天开始实施的远程缺血调节将改善 180 天的梗死体积和临床结果。材料和方法：我们进行了一项单中心双盲随机对照试验。我们纳入了所有连续入院急诊神经内科的急性缺血性卒中患者，不适合再灌注治疗，从发病起 24 小时内。在住院的前 5 天，所有受试者都被分配接受卒中二级预防治疗以及非瘫痪上肢的远程缺血调理，每天两次 - 手臂周围的血压袖带充气至收缩压以上 20 mmHg实验组最高压力（最高 180 mmHg），假手术组最高压力为 30 mmHg。主要结果是 180 天时梗死体积（通过脑 CT 扫描测量）与基线的差异，而次要结果包括临床评分（NIHSS、mRS、IADL、ADL）和认知/情绪变化（MoCA、PHQ）的差异-9) 在 180 天时与基线相比。结果：我们招募了 40 名患者；平均年龄为 65 岁，60% 是男性。干预组的受试者在残疾方面的恢复稍好，正如入院和 6 个月之间残疾评分的差异所证明的（例如，Barthel 的中位数差异评分在假手术组为 -10，在干预组为 -17.5，ADL 在假手术组为 -2，在假手术组为 -2.5干预组），以及认知表现（MoCA 的中位数差异评分在假手术组中为 -2，在干预组中为 -3），但这些差异均未达到统计学显着性。两组的症状严重程度（两组 NIHSS 的中位数差异评分 = 5）和抑郁率（两组 PHQ-9 的中位数差异评分 = 0）相似。与介入组相比，假手术组 6 个月时基线梗死体积和最终梗死体积之间的中位数差异略大（p = 0.4），可能是由于前者的初始梗死体积较大。结论：我们的结果表明远程缺血调节可能会改善残疾和认知。假手术组的基线梗塞体积和 180 天时的最终梗塞体积之间的差异略大。