Original Investigation 

August 16, 2022

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, et al

JAMA. 2022;328(7):627-636. doi:10.1001/jama.2022.13123

Key Points

Question  Does remote ischemic conditioning, which involves repeated occlusion/release cycles on bilateral upper limb arteries, improve neurologic function in patients with acute moderate ischemic stroke?

Findings  In this randomized clinical trial that included 1893 patients with acute moderate ischemic stroke, excellent neurologic function at 90 days in those randomized to remote ischemic conditioning compared with usual care occurred in 67.4% vs 62.0%, a difference that was statistically significant.

Meaning  Although remote ischemic conditioning was associated with better neurologic function in patients with acute moderate ischemic stroke, this trial requires replication before concluding efficacy for this intervention.

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.

Trial Registration  ClinicalTrials.gov Identifier: NCT03740971