Department of Neurology, General Hospital of Northern Theater Command
Shenyang, 110016, China
Location status: Recruiting
NCT Number: NCT06931535
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Shenyang, 110016, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 90±7 days
Excellent outcome is defined as modified Rankin Scale (mRS) score of 0-1. mRS ranges from 0-6, higher scores mean a worse outcome
Time frame: 90±7 days
Favorable outcome is defined as modified Rankin Scale (mRS) score of 0-2. mRS ranges from 0-6, higher scores mean a worse outcome
Time frame: 90±7 days
mRS scores range from 0 to 6. mRS ranges from 0-6, higher scores mean a worse outcome.
Time frame: 24±6 hours
NIHSS scores range 0-42, with higher scores indicating greater stroke severity
Time frame: 10±2 days
NIHSS scores range 0-42, with higher scores indicating greater stroke severity
Time frame: 10±2 days or during hospitalization, whichever is earlier.
SAP is defined according to the recommendation from the pneumonia in stroke consensus group (Stroke. 2015; 46:2335-40.)
Time frame: 90±7 days
Time frame: 90±7 days
General Hospital of Shenyang Military Region
Other
Remote Ischemic Conditioning for Acute Moderate Posterior Ischemic Stroke (RICAMIS2): a Prospective, Random, Open Label, Blinded End Point, Multi-center Study
Acronym: RICAMIS2
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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