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; Duolao Wang

doi:10.1001/jama.2022.13123

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 LiDong 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, Duolao Wang

Clinical Sciences

Research output: Contribution to journal › Article › peer-review

124 Citations (Scopus)

Abstract

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.

Original language	English
Pages (from-to)	627-636
Number of pages	10
Journal	JAMA
Volume	328
Issue number	7
DOIs	https://doi.org/10.1001/jama.2022.13123
Publication status	Published - 16 Aug 2022

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10.1001/jama.2022.13123

JAMA-Effect of Remote Ischemic Conditioning vs Usual Care on Neurological Function in Patients with Acute Moderate Ischemic StrokeAccepted author manuscript, 1.18 MB

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Chen, H. S., Cui, Y., Li, X. Q., Wang, X. H., Ma, Y. T., Zhao, Y., Han, J., Deng, C. Q., Hong, M., Bao, Y., Zhao, L. H., Yan, T. G., Zou, R. L., Wang, H., Li, Z., Wan, L. S., Zhang, L., Wang, L. Q., Guo, L. Y., ... Wang, D. (2022). Effect of Remote Ischemic Conditioning vs Usual Care on Neurologic Function in Patients With Acute Moderate Ischemic Stroke: The RICAMIS Randomized Clinical Trial. JAMA, 328(7), 627-636. https://doi.org/10.1001/jama.2022.13123

@article{82c9e86257f64144a0b872fac9303fd8,

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

abstract = "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.",

author = "Chen, \{Hui Sheng\} and Yu Cui and Li, \{Xiao Qiu\} and Wang, \{Xin Hong\} and Ma, \{Yu Tong\} and Yong Zhao and Jing Han and Deng, \{Chang Qing\} and Mei Hong and Ying Bao and Zhao, \{Li Hong\} and Yan, \{Ting Guang\} and Zou, \{Ren Lin\} and Hui Wang and Zhuo Li and Wan, \{Li Shu\} and Li Zhang and Wang, \{Lian Qiang\} and Guo, \{Li Yan\} and Li, \{Ming Nan\} and Wang, \{Dong Qing\} and Qiang Zhang and Chang, \{Da Wei\} and Zhang, \{Hong Li\} and Jing Sun and Chong Meng and Zhang, \{Zai Hui\} and Shen, \{Li Ying\} and Li Ma and Wang, \{Gui Chun\} and Li, \{Run Hui\} and Ling Zhang and Cheng Bi and Wang, \{Li Yun\} and Duolao Wang",

year = "2022",

month = aug,

day = "16",

doi = "10.1001/jama.2022.13123",

language = "English",

volume = "328",

pages = "627--636",

journal = "JAMA",

issn = "0098-7484",

publisher = "American Medical Association",

number = "7",

}

Chen, HS, Cui, Y, Li, XQ, Wang, XH, Ma, YT, Zhao, Y, Han, J, Deng, CQ, Hong, M, Bao, Y, Zhao, LH, Yan, TG, Zou, RL, Wang, H, Li, Z, Wan, LS, Zhang, L, Wang, LQ, Guo, LY, Li, MN, Wang, DQ, Zhang, Q, Chang, DW, Zhang, HL, Sun, J, Meng, C, Zhang, ZH, Shen, LY, Ma, L, Wang, GC, Li, RH, Zhang, L, Bi, C, Wang, LY & Wang, D 2022, 'Effect of Remote Ischemic Conditioning vs Usual Care on Neurologic Function in Patients With Acute Moderate Ischemic Stroke: The RICAMIS Randomized Clinical Trial.', JAMA, vol. 328, no. 7, pp. 627-636. https://doi.org/10.1001/jama.2022.13123

TY - JOUR

T1 - Effect of Remote Ischemic Conditioning vs Usual Care on Neurologic Function in Patients With Acute Moderate Ischemic Stroke: The RICAMIS Randomized Clinical Trial.

AU - Chen, Hui Sheng

AU - Cui, Yu

AU - Li, Xiao Qiu

AU - Wang, Xin Hong

AU - Ma, Yu Tong

AU - Zhao, Yong

AU - Han, Jing

AU - Deng, Chang Qing

AU - Hong, Mei

AU - Bao, Ying

AU - Zhao, Li Hong

AU - Yan, Ting Guang

AU - Zou, Ren Lin

AU - Wang, Hui

AU - Li, Zhuo

AU - Wan, Li Shu

AU - Zhang, Li

AU - Wang, Lian Qiang

AU - Guo, Li Yan

AU - Li, Ming Nan

AU - Wang, Dong Qing

AU - Zhang, Qiang

AU - Chang, Da Wei

AU - Zhang, Hong Li

AU - Sun, Jing

AU - Meng, Chong

AU - Zhang, Zai Hui

AU - Shen, Li Ying

AU - Ma, Li

AU - Wang, Gui Chun

AU - Li, Run Hui

AU - Zhang, Ling

AU - Bi, Cheng

AU - Wang, Li Yun

AU - Wang, Duolao

PY - 2022/8/16

Y1 - 2022/8/16

N2 - 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.

AB - 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.

U2 - 10.1001/jama.2022.13123

DO - 10.1001/jama.2022.13123

M3 - Article

SN - 0098-7484

VL - 328

SP - 627

EP - 636

JO - JAMA

JF - JAMA

IS - 7

ER -

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

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