Safety and Efficacy of Remote Ischemic Conditioning in Patients With Intravenous Thrombolysis: The SERIC-IVT Trial
Authors: Guo Zhen-Ni , Abuduxukuer Reziya , Zhang Peng , Qu Yang , Wang Li-Juan , Zhao Jun-Feng , Ju Dong-Sheng , Wang Jun-Min , Jin Hui-Min , Wang Wei-Wei , Teng Rui-Hong , Gao Jian-Hua , Yuan Zhi-Mei , Gao Hui-Fang , Jiang Yong-Fei , Li Zhi-Dan , He Ying , Jiang Li-Gang , Li Li , Hu Xue-Feng , Jiang Chun-Li , Wang Rui , Qi Ying-Bin , Xin Hong , Jia Yan , Yu Hong , Jin Hang , Chen Hui-Sheng , Wang Duo-Lao , Nguyen Thanh N. , Yang Yi , Zhang Feng-Jiao , Zhang Huai-Mei , Liu Jia-Cheng , Ren Jia-Xin , Zhang Ke-Jia , He Qian-Yan , Lei Shuang-Yin , Wang Si-Ji , Yin Wen-Jing , Yan Xiu-Li , Sun Ye , Shen Zi-Duo , Wang Jin-Qi , Wang Ting , Pan De-Wang , Tan Shuang-Xu , Zhang Xian-Kun , Zheng Yang , Li Yu , Li Zhi-Guo , Han Ce , Li Chun-Ying , Yao Jing , Teng Fei-Yue , Liang He , Yang Hong-Yu , Gao Jian , Wang Jin-Cheng , Tang Jing , Chen Jin-Hua , Zhao Li-Li , Zhang Miao , Wang Wei-Jia , Liu An-Ran , Lv Dian-Ping , Zhao Feng-Lan , Gu Ji-Liang , Li Yang , Liu Nan , Zhao Qi , Li Shi-Wei , Wang Shu-Guo , Cui Yan , Wang Chun-Fei , Chen Hai-Nan , Zhang Lu-Ping , Zou Xue-Xia , Pei Zhong-Rui , Yang Li-Chong , Chen Yu-Mei , Liu Bing-Hua , Zou Guang-Chen , Ju Hui-Lian , Yu Jing-Yao , Xiao Jin-Xin , Sui Juan , Li Kun , Xia Li , Jiang Mei-Mei , Sun Na , Li Shan , Li Si-Long , Ding Xian-Qin , Yang Chun-Yu , Li Dan , Li Guang-Cai , Wu Lei , He Li-Li , Chen Li-Ping , Chang Ming , Li Tao , Gou Wei , Liu Xiao-Nan , Cheng Xiao-Ying , Wang Ya-Li , Ba Yun-Fei , Liu Li , Zhang Bai-Jing , Dong Chen-Peng , Xu Han , Li Hao , Li Jin-Feng , Xu Jing , Liu Liang , Sun Li-Ming , Zhang Li-Ying , Sun Qi-Dong , Liu Xue , Dong Yang , Chen Zhi-Bo , Shi Zhuang-Hong , Wang An-Ying , Guo Li-Jie , Liu Ming , Gu Yan-Qiu , Wang Yu , Ma Chun-Yan , Xue Jing , Liu Liang-Yan , Pang Meng , Li Song , Zhang Xin , Zhang Xun-Juan , Song Yang-Yang , Zhang Yu , Wang Cui , Xu Dan , Yang Dong-Xue , Liu Fang-Fang , Li Fu-Jin , Sun Jie-Hong , Niu Li-Ming , He Ling , Liu Li-Yan , Yu Shuang , Sun Si-Yin , Shi Tian-Ji , Zhang Wen-Bo , Ma Wen-Juan , Song Wen-Tong , Liu Xiu-Ping , Jia Yan , Li Ying-Kui , Yang Qiu , Zhang Wei , Su Wen-Shuai , Li Xin , Yang Yang , Cai Ying-Chao , Liu Yu-Ting 
Published: January 2025

BACKGROUND:
Approximately half of the patients with acute ischemic stroke who receive intravenous thrombolysis (IVT) do not achieve an excellent outcome. Remote ischemic conditioning (RIC) as a promising neuroprotective treatment may improve clinical outcomes in this population. This study aimed to assess the efficacy and safety of RIC in patients with IVT.

METHODS:
This multicenter, participant-blinded, blinded end point, randomized controlled clinical trial included 558 patients with acute ischemic stroke who underwent IVT in 18 hospitals from August 2021 to May 2023. After IVT, patients were randomized 1:1 to the RIC (unilateral upper limb; cuff pressure, 200 mm Hg, twice daily for 7 days) or sham RIC groups (the same procedure; cuff pressure, 60 mm Hg). The primary efficacy outcome was an excellent functional outcome (modified Rankin Scale score, 0–1) at 90 days after IVT.

RESULTS:

In total, 558 eligible patients were randomized, and 11 (2.0%) were excluded because they did not receive an RIC or sham RIC. Thus, 547 patients (RIC, n=274; sham RIC, n=273) were included in the modified intention-to-treat analysis, of whom 15 patients were lost to follow-up and 532 (95.3%) completed the trial. At 90 days, 62.7% of patients in the RIC group and 56.8% in the sham RIC group had an excellent functional outcome (unadjusted risk ratio, 1.10 [95% CI, 0.96–1.27];
P
=0.169). The proportion of patients with any adverse events was 11.2% in the RIC group and 8.1% in the sham RIC group, with no significant difference (
P
=0.221).

CONCLUSIONS:
RIC was safe in patients with acute ischemic stroke who received IVT. However, it did not significantly improve excellent functional outcome.

REGISTRATION:

URL:
https://www.clinicaltrials.gov
; Unique identifier: NCT04980625.