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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years;

• Time from onset to treatment: ≤48 hours;

• Posterior circulation ischemic stroke confirmed by CT or MRI, including patients who have received intravenous thrombolysis or endovascular therapy;

• NIHSS score at randomization: 6-16, with an item 1a (level of consciousness) score of 0-1;

• First-ever stroke or prior stroke without significant residual disability (modified Rankin Scale score ≤1);

• Signed informed consent.

Locations
Other Locations
China
Department of Neurology, General Hospital of Northern Theater Command
RECRUITING
Shenyang
Time Frame
Start Date: 2025-04-13
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 960
Treatments
No_intervention: control
standard stroke care
Experimental: RIC group
remote ischemic conditioning, twice a day, for 10 days.
Related Therapeutic Areas
Sponsors
Leads: General Hospital of Shenyang Military Region

This content was sourced from clinicaltrials.gov

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