NCT06931535

Remote Ischemic Conditioning for Acute Moderate Posterior Ischemic Stroke

Remote Ischemic Conditioning for Acute Moderate Posterior Ischemic Stroke (RICAMIS2): a Prospective, Random, Open Label, Blinded End Point, Multi-center Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 960 (estimated)
• Sponsor: General Hospital of Shenyang Military Region · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A substantial body of basic and clinical research has demonstrated the protective effects of remote ischemic conditioning (RIC) in ischemic stroke. While these clinical studies support the safety of RIC, the neuroprotective benefits of RIC in acute ischemic stroke (AIS) patients lack robust evidence due to small sample sizes, heterogeneous RIC protocols, and variability in the severity of neurological deficits among study populations. Our recent multicenter randomized clinical trial, the RICAMIS study, investigated the efficacy of RIC in patients with acute moderate ischemic stroke. The results showed that RIC administered within 48 hours of onset significantly improved 90-day neurological outcomes in patients with moderate stroke severity. It is well established that anterior circulation stroke (ACS) and posterior circulation stroke (PCS) differ in multiple aspects, including anatomical structure, collateral circulation, blood supply, clinical manifestations, prognosis, ischemic tolerance time, and treatment response. For instance, compared to the anterior circulation, the posterior circulation has poorer collateral circulation, a higher proportion of stroke etiologies attributed to atherosclerosis, and longer ischemic tolerance time. Consequently, intravenous thrombolysis and endovascular therapy may offer a more extended therapeutic time window for PCS patients. A prespecified subgroup analysis of the RICAMIS study revealed that patients with PCS derived greater benefit from RIC than those with ACS. However, this finding requires further validation through prospective studies, as prior research has never specifically examined the efficacy of RIC in PCS patients. Based on the above discussion, this study aims to investigate the efficacy and safety of RIC in patients with acute moderate PCS.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
DEVICE	remote ischemic conditioning	The cuff of the remote ischemic conditioning device was placed on both upper arms (at the same position as blood pressure measurement) and inflated to 200 mmHg. The treatment protocol consisted of 5 cycles of 5-minute inflation followed by 5-minute deflation, performed twice daily. The treatment duration was 8-12 consecutive days.

Timeline

• Start date: 2025-04-13
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2025-04-17
• Last updated: 2025-04-25

Locations

1 site across 1 country: China