Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.
Department of Rehabilitation Medicine, University of Alberta, Edmonton, Alberta, Canada.
PLoS One. 2023 May 4;18(5):e0284879. doi: 10.1371/journal.pone.0284879. eCollection 2023.
Remote ischemic conditioning (RIC) is delivered by a blood pressure cuff over the limb, raising pressure 50 mmHg above the systolic blood pressure, to a maximum of 200 mmHg. The cuff is inflated for five minutes and then deflated for five minutes in a sequential ischemia-reperfusion cycle 4-5 times per session. Elevated pressure in the limb may be associated with discomfort and consequently reduced compliance. Continuous assessment of relative blood concentration and oxygenation with a tissue reflectance spectroscopy (a type of optical sensor device) placed over the forearm during the RIC sessions of the arm will allow us to observe the effect of inflation and deflation of the pressure cuff. We hypothesize, in patients with acute ischemic stroke (AIS) and small vessel disease, RIC delivered together with a tissue reflectance sensor will be feasible.
The study is a prospective, single-center, randomized control trial testing the feasibility of the device. Patients with AIS within 7 days from symptoms onset; who also have small vessel disease will be randomized 2:1 to intervention or sham control arms. All patients randomized to the intervention arm will receive 5 cycles of ischemia/reperfusion in the non-paralyzed upper limb with a tissue reflectance sensor and patients in the sham control arm will receive pressure by keeping the cuff pressure at 30 mmHg for 5 minutes. A total of 51 patients will be randomized, 17 in the sham control arm and 34 in the intervention arm. The primary outcome measure will be the feasibility of RIC delivered for 7 days or at the time of discharge. The secondary device-related outcome measures are fidelity of RIC delivery and the completion rate of intervention. The secondary clinical outcome includes a modified Rankin scale, recurrent stroke and cognitive assessment at 90 days.
RIC delivery together with a tissue reflectance sensor will allow insight into the blood concentration and blood oxygenation changes in the skin. This will allow individualized delivery of the RIC and improve compliance.
ClinicalTrials.gov Identifier: NCT05408130, June 7, 2022.
远程缺血预处理（RIC）通过肢体上的血压袖带施加，将压力升高至比收缩压高 50mmHg，最高可达 200mmHg。袖带充气 5 分钟，然后在每个会话的 4-5 个缺血-再灌注循环中放气 5 分钟。肢体中的高压可能会引起不适，从而降低顺应性。在 RIC 期间，在前臂上放置组织反射光谱仪（一种光学传感器设备），连续评估相对血液浓度和氧合作用，将允许我们观察充气和放气袖带的效果。我们假设，在急性缺血性脑卒中（AIS）和小血管疾病患者中，与组织反射传感器一起施加的 RIC 是可行的。
该研究是一项前瞻性、单中心、随机对照试验，旨在测试该设备的可行性。症状发作后 7 天内患有 AIS 的患者；并且患有小血管疾病的患者将被随机分为 2:1 的干预组或假控制组。所有随机分配到干预组的患者将在非瘫痪的上肢中接受 5 个缺血/再灌注循环，同时使用组织反射传感器，而假控制组的患者将通过将袖带压力保持在 30mmHg 5 分钟来接受压力。总共将随机分配 51 名患者，假控制组 17 名，干预组 34 名。主要结局测量指标将是 7 天或出院时的 RIC 可行性。次要设备相关结局测量指标是 RIC 输送的保真度和干预的完成率。次要临床结局包括 90 天时的改良 Rankin 量表、复发性卒中和认知评估。
RIC 与组织反射传感器一起输送将可以深入了解皮肤中的血液浓度和血氧变化。这将允许个性化地输送 RIC，并提高顺应性。
ClinicalTrials.gov 标识符：NCT05408130，2022 年 6 月 7 日。
