Purroy Francisco, Arque Gloria, Mauri Gerard, García-Vázquez Cristina, Vicente-Pascual Mikel, Pereira Cristina, Vazquez-Justes Daniel, Torres-Querol Coral, Vena Ana, Abilleira Sònia, Cardona Pere, Forné Carles, Jiménez-Fàbrega Xavier, Pagola Jorge, Portero-Otin Manuel, Rodríguez-Campello Ana, Rovira Àlex, Martí-Fàbregas Joan
Stroke Unit, Department of Neurology, Hospital Universitari Arnau de Vilanova de Lleida, Lleida, Spain.
Clinical Neurosciences Group, Institut de Recerca Biomèdica de Lleida (IRBLleida), Universitat de Lleida, Lleida, Spain.
Front Neurol. 2020 Sep 25;11:569696. doi: 10.3389/fneur.2020.569696. eCollection 2020.
Remote ischemic perconditioning during cerebral ischemia (RIPerC) refers to the application of brief episodes of transient limb ischemia commonly to a limb, it represents a new safe, simple and low-cost paradigm in neuroprotection. To evaluate the effects of RIPerC on acute ischemic stroke (AIS) patients, applied in the ambulance, to improve functional outcomes compared with standard of care. A sample size of 286 patients in each arm achieves 80% power to detect treatment differences of 14% in the outcome, using a two-sided binomial test at significance level of 0.05, assuming that 40% of the control patients will experience good outcome and an initial misdiagnosis rate of 29%. We aim to conduct a multicentre study of pre-hospital RIPerC application in AIS patients. A total of 572 adult patients diagnosed of suspected clinical stroke within 8 h of symptom onset and clinical deficit >0 according to prehospital rapid arterial occlusion evaluation (RACE) scale score will be randomized, in blocks of size 4, to RIPerC or sham. Patients will be stratified by RACE score scale. RIPerC will be started in the ambulance before hospital admission and continued in the hospital if necessary. It will consist of five cycles of electronic tourniquet inflation and deflation (5 min each). The cuff pressure for RIPerC will be 200 mmHg during inflation. Sham will only simulate vibration of the device. The primary outcome will be the difference in the proportion of patients with good outcomes as defined by a mRS score of 2 or less at 90 days. Secondary outcomes to be monitored will include early neurological improvement rate, treatment related serious adverse event rates, size of the infarct volume, symptomatic intracranial hemorrhage, metabolomic and lipidomic response to RIPerC and Neuropsychological evaluation at 90 days. Neuroprotective therapies could not only increase the benefits of available reperfusion therapies among AIS patients but also provide an option for patients who are not candidates for these treatments. REMOTE-CAT will investigate the clinical benefit of RIC as a new neuroprotective strategy in AIS. www.ClinicalTrials.gov, identifier: NCT03375762.
脑缺血期间的远程缺血预处理（RIPerC）是指通常对肢体施加短暂的肢体缺血发作，它代表了一种新的安全、简单且低成本的神经保护模式。为了评估RIPerC对急性缺血性中风（AIS）患者的影响，在救护车上应用，以与标准治疗相比改善功能结局。每组286名患者的样本量在显著性水平为0.05时，使用双侧二项式检验，在假设40%的对照患者将获得良好结局且初始误诊率为29%的情况下，有80%的把握检测出结局中14%的治疗差异。我们旨在对AIS患者进行院前RIPerC应用的多中心研究。总共572名在症状发作8小时内被诊断为疑似临床中风且根据院前快速动脉闭塞评估（RACE）量表评分临床缺损>0的成年患者将按4人一组进行随机分组，分为RIPerC组或假手术组。患者将按RACE评分量表进行分层。RIPerC将在入院前的救护车上开始，如有必要在医院继续进行。它将包括五个电子止血带充气和放气周期（每个周期5分钟）。RIPerC充气期间的袖带压力将为200 mmHg。假手术仅模拟设备的振动。主要结局将为90天时改良Rankin量表（mRS）评分为2分或更低所定义的良好结局患者比例的差异。要监测的次要结局将包括早期神经功能改善率、治疗相关严重不良事件发生率、梗死体积大小、症状性颅内出血、对RIPerC的代谢组学和脂质组学反应以及90天时的神经心理学评估。神经保护疗法不仅可以增加AIS患者中现有再灌注疗法的益处，还可以为不适合这些治疗的患者提供一种选择。REMOTE-CAT将研究RIC作为AIS中新的神经保护策略带来的临床益处。www.ClinicalTrials.gov，标识符：NCT03375762。
