Effect of Remote Ischemic Conditioning vs Usual Care on Neurologic Function in Patients With Acute Moderate Ischemic Stroke: The RICAMIS Randomized Clinical Trial.,JAMA

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Effect of Remote Ischemic Conditioning vs Usual Care on Neurologic Function in Patients With Acute Moderate Ischemic Stroke: The RICAMIS Randomized Clinical Trial.
JAMA ( IF 63.1 ) Pub Date : 2022-08-16 , DOI: 10.1001/jama.2022.13123
Hui-Sheng Chen ₁ , Yu Cui ₁ , Xiao-Qiu Li ₁ , Xin-Hong Wang ₁ , Yu-Tong Ma ₂ , Yong Zhao ₃ , Jing Han ₄ , Chang-Qing Deng ₅ , Mei Hong ₆ , Ying Bao ₇ , Li-Hong Zhao ₈ , Ting-Guang Yan ₉ , Ren-Lin Zou ₁₀ , Hui Wang ₁₁ , Zhuo Li ₄ , Li-Shu Wan ₁₂ , Li Zhang ₁₃ , Lian-Qiang Wang ₁₄ , Li-Yan Guo ₁₅ , Ming-Nan Li ₁₆ , Dong-Qing Wang ₁₇ , Qiang Zhang ₁₈ , Da-Wei Chang ₁₉ , Hong-Li Zhang ₂₀ , Jing Sun ₂₁ , Chong Meng ₂₂ , Zai-Hui Zhang ₂₃ , Li-Ying Shen ₂₄ , Li Ma ₂₅ , Gui-Chun Wang ₂₆ , Run-Hui Li ₂₅ , Ling Zhang ₂₇ , Cheng Bi ₅ , Li-Yun Wang ₂₈ , Duo-Lao Wang ₂₉ ,

Affiliation

Department of Neurology, General Hospital of Northern Theatre Command, Shenyang, China.
Department of Neurology, Beipiao Central Hospital, Beipiao, China.
Department of Neurology, Haicheng Chinese Medicine Hospital, Haicheng, China.
Department of Neurology, Panjin Central Hospital, Panjin, China.
Department of Neurology, Dandong Central Hospital, Dandong, China.
Department of Neurology, China Railway 19th Bureau Group Central Hospital, Liaoyang, China.
Department of Neurology, Fuxin Second People's Hospital, Fuxin, China.
Department of Neurology, Dandong People's Hospital, Dandong, China.
Department of Neurology, Chaoyang Central Hospital, Chaoyang, China.
Department of Neurology, Wafangdian Third Hospital, Dalian, China.
Department of Neurology, Chinese People's Liberation Army 230 Hospital, Dandong, China.
Department of Neurology, Dandong First Hospital, Dandong, China.
Department of Neurology, Suizhong County Hospital, Huludao, China.
Department of Neurology, Liaoyang County Stroke Hospital, Liaoyang, China.
Department of Neurology, Fushun Second Hospital, Fushun, China.
Department of Neurology, Huanren Manchu Autonomous County People's Hospital, Benxi, China.
Department of Neurology, Panjin People's Hospital, Panjin, China.
Department of Neurology, Fushun Central Hospital, Fushun, China.
Department of Neurology, Sujiatun Stroke Hospital, Shenyang, China.
Department of Neurology, Taian County Chinese Medicine Hospital, Anshan, China.
Department of Neurology, Anshan Hospital, The First Affiliated Hospital of China Medical University, Anshan, China.
Department of Neurology, Liaoyang County Central Hospital, Liaoyang, China.
Department of Neurology, Xiuyan County Central Hospital, Anshan, China.
Department of Neurology, Tieling County Central Hospital, Tieling, China.
Department of Neurology, The Affiliated Central Hospital of Shenyang Medical College, Shenyang, China.
Department of Neurology, Changtu County Central Hospital, Tieling, China.
Department of Neurology, Dengta Central Hospital, Dengta, China.
Department of Neurology, Liaoyang Petrochemical General Hospital, Liaoyang, China.
Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.

Importance Preclinical 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. Objective To assess the efficacy of RIC for acute moderate ischemic stroke. Design, Setting, and Participants This 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. Interventions Eligible 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 Measures The 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. Results Among 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 Relevance Among 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 Registration ClinicalTrials.gov Identifier: NCT03740971.

更新日期：2022-08-16

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