Remote limb ischemic conditioning treatment for intracranial atherosclerotic stenosis patients

OBJECTIVE: The recurrence rate of ischemic stroke remains high among symptomatic intracranial atherosclerotic stenosis patients with either ischemic stroke or transient ischemic attack. The aim of our study is to evaluate whether remote limb ischemic conditioning (RLIC) prevents cerebral ischemic events in symptomatic intracranial atherosclerotic stenosis patients. METHODS: Symptomatic intracranial atherosclerotic stenosis patients with either ischemic stroke or transient ischemic attack will be recruited from more than 60 hospitals in China to participate in a randomized, double-blind, parallel-controlled clinical trial that will compare the efficacy and safety of RLIC for the prevention of recurrent stroke. Following randomization, patients allocated to the RLIC group (n = 1500) will receive RLIC once daily for 12 months, with treatment consisting of five cycles of 5 min of pressure treatment at 200 mm Hg, followed by 5 min of reperfusion. The sham group (n = 1500) will be treated identically, with the exception of pressure treatment at 60 mm Hg. RESULTS: The primary endpoint will be an ischemic stroke event during the study period. Secondary endpoints will include composite fatal and nonfatal stroke, fatal and nonfatal myocardial infarction, and transient ischemic attack. Patients will be assessed periodically over a approximate 3-year study period using the modified Rankin Scale, National Institutes of Health Stroke Scale, and Barthel Activities of Daily Living Index. CONCLUSION: We predict that RLIC treatment for 12 months will safely reduce the ischemic stroke recurrence rate.