About this trial
The purpose of this study is to explore the safety and efficacy of remote ischemic conditioning in patients with internal carotid artery occlusion receiving hybird surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age≥18 years, regardless of sex
Patients with chronic carotid artery occlusion who are going to undergo hybird surgery
Can cooperate with and complete brain magnetic resonance imaging (MRI) examination
Signed and dated informed consent is obtained
Disqualifiers
Hemorrhagic stroke
Severe cardiac dysfunction or arrhythmia
Uncontrolled hypertension (defined as systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg, despite medication taken at enrollment)
Severe hepatic and renal dysfunction (defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3 times higher than the upper limit of the normal range, creatinine >265umol/l (3mg/dl))
Trial design
Parallel
Treatments tested in this trial
Remote ischemic conditioning
DeviceRemote ischemic conditioning: Remote ischemic conditioning (RIC) is induced by 5 cycles of 5 min of bilateral upper limbs ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 200 mmHg.
Sham remote ischemic conditioning
DeviceSham remote ischemic conditioning (RIC) is induced by 5 cycles of 5 min of bilateral upper limbs ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 60 mmHg.
Treatment groups
Trial outcomes
Primary outcomes
Proportion of patients with new Diffusion Weighted Imaging (DWI) - positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.
Patients will undergo magnetic resonance imaging (including DWI) at baseline and 6 days after randomization.
Secondary outcomes
The number of new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.
Patients will undergo magnetic resonance imaging (including DWI)at baseline and 6 days after randomization.
The volume of new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.
Patients will undergo magnetic resonance imaging(including DWI) at baseline and 6 days after randomization.
Number of patients with cerebrovascular events, cardiovascular events or death
Cerebrovascular events include ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage. Cardiovascular events include angina and myocardial infarction. Death include all-cause of death.
Proportion of patients with any side effects of RIC treatment.
The side effects referred to any side effects of RIC or sham RIC treatment, not including the sides effect of medications or hybrid surgery.
Locations
Sponsors and contacts
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Yi Yang
Lead sponsor
The First Hospital of Jilin University
Sponsor institution
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