Ishizuka Kentaro, Hoshino Takao, Toi Sono, Mizuno Takafumi, Hosoya Megumi, Saito Moeko, Sato Yasuto, Yagita Yoshiki, Todo Kenichi, Sakaguchi Manabu, Ohashi Takashi, Maruyama Kenji, Hino Shuji, Honma Yutaka, Doijiri Ryosuke, Yamagami Hiroshi, Iguchi Yasuyuki, Hirano Teruyuki, Kimura Kazumi, Kitazono Takanari, Kitagawa Kazuo
Department of Neurology, Tokyo Women's Medical University School of Medicine, Tokyo, Japan.
Department of Public Health, Tokyo Women's Medical University School of Medicine, Tokyo, Japan.
Front Neurol. 2022 Aug 8;13:946431. doi: 10.3389/fneur.2022.946431. eCollection 2022.
Remote ischemic conditioning (RIC) refers to the application of repeated short periods of ischemia intended to protect remote areas against tissue damage during and after prolonged ischemia.
We aim to evaluate the efficacy of RIC, determined by the modified Rankin Scale (mRS) score at 90 days after stroke onset.
This study is an investigator-initiated, multicenter, prospective, randomized, open-label, parallel-group clinical trial. The sample size is 400, comprising 200 patients who will receive RIC and 200 controls. The patients will be divided into three groups according to their National Institutes of Health Stroke Scale score at enrollment: 5-9, mild; 10-14, moderate; 15-20, severe. The RIC protocol will be comprised of four cycles, each consisting of 5 min of blood pressure cuff inflation (at 200 mmHg or 50 mmHg above the systolic blood pressure) followed by 5 min of reperfusion, with the cuff placed on the thigh on the unaffected side. The control group will only undergo blood pressure measurements before and after the intervention period. This trial is registered with the UMIN Clinical Trial Registry (https://www.umin.ac.jp/: UMIN000046225).
The primary outcome will be a good functional outcome as determined by the mRS score at 90 days after stroke onset, with a target mRS score of 0-1 in the mild group, 0-2 in the moderate group, and 0-3 in the severe group.
This trial may help determine whether RIC should be recommended as a routine clinical strategy for patients with ischemic stroke.
远程缺血预处理（RIC）是指应用反复的短时间缺血，旨在保护远隔区域在长时间缺血期间及之后免受组织损伤。
我们旨在评估RIC的疗效，通过卒中发作后90天的改良Rankin量表（mRS）评分来确定。
本研究是一项研究者发起的、多中心、前瞻性、随机、开放标签、平行组临床试验。样本量为400例，包括200例接受RIC的患者和200例对照组。患者将根据入组时的美国国立卫生研究院卒中量表评分分为三组：5 - 9分，轻度；10 - 14分，中度；15 - 20分，重度。RIC方案将包括四个周期，每个周期包括5分钟的血压袖带充气（收缩压以上200 mmHg或50 mmHg），随后是5分钟的再灌注，袖带置于患侧大腿。对照组仅在干预期前后进行血压测量。本试验已在UMIN临床试验注册中心注册（https://www.umin.ac.jp/: UMIN000046225）。
主要结局将是卒中发作后90天由mRS评分确定的良好功能结局，轻度组目标mRS评分为0 - 1分，中度组为0 - 2分，重度组为0 - 3分。
本试验可能有助于确定RIC是否应作为缺血性卒中患者的常规临床策略被推荐。
