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Randomized Controlled Trial Multicenter Study Comparative Study
Effect of Remote Ischemic Conditioning vs Usual Care on Neurologic Function in Patients With Acute Moderate Ischemic Stroke: The RICAMIS Randomized Clinical Trial.
- Hui-Sheng Chen, Yu Cui, Xiao-Qiu Li, Xin-Hong Wang, Yu-Tong Ma, Yong Zhao, Jing Han, Chang-Qing Deng, Mei Hong, Ying Bao, Li-Hong Zhao, Ting-Guang Yan, Ren-Lin Zou, Hui Wang, Zhuo Li, Li-Shu Wan, Li Zhang, Lian-Qiang Wang, Li-Yan Guo, Ming-Nan Li, Dong-Qing Wang, Qiang Zhang, Da-Wei Chang, Hong-Li Zhang, Jing Sun, Chong Meng, Zai-Hui Zhang, Li-Ying Shen, Li Ma, Gui-Chun Wang, Run-Hui Li, Ling Zhang, Cheng Bi, Li-Yun Wang, Duo-Lao Wang, and RICAMIS Investigators.
- Department of Neurology, General Hospital of Northern Theatre Command, Shenyang, China.
- JAMA. 2022 Aug 16; 328 (7): 627636627-636.
ImportancePreclinical and clinical studies have suggested a neuroprotective effect of remote ischemic conditioning (RIC), which involves repeated occlusion/release cycles on bilateral upper limb arteries; however, robust evidence in patients with ischemic stroke is lacking.ObjectiveTo assess the efficacy of RIC for acute moderate ischemic stroke.Design, Setting, And ParticipantsThis multicenter, open-label, blinded-end point, randomized clinical trial including 1893 patients with acute moderate ischemic stroke was conducted at 55 hospitals in China from December 26, 2018, through January 19, 2021, and the date of final follow-up was April 19, 2021.InterventionsEligible patients were randomly assigned within 48 hours after symptom onset to receive treatment with RIC (using a pneumatic electronic device and consisting of 5 cycles of cuff inflation for 5 minutes and deflation for 5 minutes to the bilateral upper limbs to 200 mm Hg) for 10 to 14 days as an adjunct to guideline-based treatment (n = 922) or guideline-based treatment alone (n = 971).Main Outcomes And MeasuresThe primary end point was excellent functional outcome at 90 days, defined as a modified Rankin Scale score of 0 to 1. All end points had blinded assessment and were analyzed on a full analysis set.ResultsAmong 1893 eligible patients with acute moderate ischemic stroke who were randomized (mean [SD] age, 65 [10.3] years; 606 women [34.1%]), 1776 (93.8%) completed the trial. The number with excellent functional outcome at 90 days was 582 (67.4%) in the RIC group and 566 (62.0%) in the control group (risk difference, 5.4% [95% CI, 1.0%-9.9%]; odds ratio, 1.27 [95% CI, 1.05-1.54]; P = .02). The proportion of patients with any adverse events was 6.8% (59/863) in the RIC group and 5.6% (51/913) in the control group.Conclusions And RelevanceAmong adults with acute moderate ischemic stroke, treatment with remote ischemic conditioning compared with usual care significantly increased the likelihood of excellent neurologic function at 90 days. However, these findings require replication in another trial before concluding efficacy for this intervention.Trial RegistrationClinicalTrials.gov Identifier: NCT03740971.
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