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Remote Ischemic Conditioning for Acute Stroke

医学 袖口 改良兰金量表 冲程(发动机) 随机对照试验 人口 临床试验 随机化 麻醉 物理疗法 缺血 外科 急诊医学 内科学 缺血性中风 环境卫生 机械工程 工程类
作者
Rolf Ankerlund Blauenfeldt,Niels Hjort,Jan Brink Valentin,Anne-Mette Homburg,Boris Modrau,Birgitte Forsom Sandal,Martin Faurholdt Gude,Kristina Dupont Hougaard,Dorte Damgaard,Marika Poulsen,Tove Diedrichsen,Marie Louise Schmitz,Paul von Weitzel-Mudersbach,Alex Alban Christensen,Krystian Figlewski,Erik Lerkevang Grove,Margrét Katrín Hreiðarsdóttir,Henning Morthorst Lassesen,Daniel Wittrock,Søren Mikkelsen,Ulla Væggemose,Palle Juelsgaard,Hans Kirkegaard,Martin Rostgaard-Knudsen,Niels Sanderhoff Degn,Sigrid Breinholt Vestergaard,Andreas Gammelgaard Damsbo,Ane Bull Iversen,Jens Tølbøll Mortensen,Jesper Petersson,Thomas Christensen,Anne Behrndtz,Hans Erik Bøtker,David Garcı́a-Dorado,Marc Fisher,David C. Hess,Søren Paaske Johnsen,Claus Z Simonsen,Grethe Andersen
出处
期刊:JAMA [American Medical Association]
卷期号:330 (13): 1236-1236 被引量:2
标识
DOI:10.1001/jama.2023.16893
摘要

Importance Despite some promising preclinical and clinical data, it remains uncertain whether remote ischemic conditioning (RIC) with transient cycles of limb ischemia and reperfusion is an effective treatment for acute stroke. Objective To evaluate the effect of RIC when initiated in the prehospital setting and continued in the hospital on functional outcome in patients with acute stroke. Design, Setting, and Participants This was a randomized clinical trial conducted at 4 stroke centers in Denmark that included 1500 patients with prehospital stroke symptoms for less than 4 hours (enrolled March 16, 2018, to November 11, 2022; final follow-up, February 3, 2023). Intervention The intervention was delivered using an inflatable cuff on 1 upper extremity (RIC cuff pressure, ≤200 mm Hg [n = 749] and sham cuff pressure, 20 mm Hg [n = 751]). Each treatment application consisted of 5 cycles of 5 minutes of cuff inflation followed by 5 minutes of cuff deflation. Treatment was started in the ambulance and repeated at least once in the hospital and then twice daily for 7 days among a subset of participants. Main Outcomes and Measures The primary end point was improvement in functional outcome measured as a shift across the modified Rankin Scale (mRS) score (range, 0 [no symptoms] to 6 [death]) at 90 days in the target population with a final diagnosis of ischemic or hemorrhagic stroke. Results Among 1500 patients who were randomized (median age, 71 years; 591 women [41%]), 1433 (96%) completed the trial. Of these, 149 patients (10%) were diagnosed with transient ischemic attack and 382 (27%) with a stroke mimic. In the remaining 902 patients with a target diagnosis of stroke (737 [82%] with ischemic stroke and 165 [18%] with intracerebral hemorrhage), 436 underwent RIC and 466 sham treatment. The median mRS score at 90 days was 2 (IQR, 1-3) in the RIC group and 1 (IQR, 1-3) in the sham group. RIC treatment was not significantly associated with improved functional outcome at 90 days (odds ratio [OR], 0.95; 95% CI, 0.75 to 1.20, P = .67; absolute difference in median mRS score, −1; −1.7 to −0.25). In all randomized patients, there were no significant differences in the number of serious adverse events: 169 patients (23.7%) in the RIC group with 1 or more serious adverse events vs 175 patients (24.3%) in the sham group (OR, 0.97; 95% CI, 0.85 to 1.11; P = .68). Upper extremity pain during treatment and/or skin petechia occurred in 54 (7.2%) in the RIC group and 11 (1.5%) in the sham group. Conclusions and Relevance RIC initiated in the prehospital setting and continued in the hospital did not significantly improve functional outcome at 90 days in patients with acute stroke. Trial Registration ClinicalTrials.gov Identifier: NCT03481777
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