机构:[1]Center for Evidence Based Medicine, Xuanwu Hospital Capital Medical University, Beijing, China首都医科大学宣武医院循证医学中心[2]Department of Neurology, Xuanwu Hospital Capital Medical University, Beijing, China神经内科首都医科大学宣武医院[3]Cerebrovascular Disease Laboratory, Xuanwu Hospital Capital Medical University, Beijing, China首都医科大学宣武医院脑血管病转化医学北京市重点实验室[4]Clinical Research Center, Peking University Health Science Center, Beijing, China[5]Department of Neurosurgery, Xuanwu Hospital Capital Medical University, Beijing, China神经外科首都医科大学宣武医院[6]Department of Cardiology, Xuanwu Hospital Capital Medical University, Beijing, China心脏科(内科专业)首都医科大学宣武医院
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 5min of pressure treatment at 200mm Hg, followed by 5min of reperfusion. The sham group (n=1500) will be treated identically, with the exception of pressure treatment at 60mm 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.
基金:
Xuanwu Hospital of Capital Medical University scientific research funds.