The purpose of this study is to explore the safety and efficacy of remote ischemic conditioning in patients with carotid artery stenosis undergoing carotid endarterectomy.
In this study, 100 patients with carotid artery stenosis undergoing carotid endarterectomy are included in our center in China according to the principle of random, and parallel control. The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times per day for 6 consecutive days. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times per day for 6 consecutive days. Two groups will be followed up for 1 year to evaluate the safety and efficacy of remote ischemic conditioning in patients with carotid artery stenosis undergoing carotid endarterectomy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
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.
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.
The First Hospital of Jilin University
Changchun, Jilin, China
Proportion of patients who got ≥1 new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.
Patients underwent magnetic resonance imaging (including DWI)at baseline and 6 days after randomization.
Time frame: 6 days
The number of new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.
Patients underwent magnetic resonance imaging (including DWI)at baseline and 6 days after randomization.
Time frame: 6 days
The volume of new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans.
Patients underwent magnetic resonance imaging(including DWI) at baseline and 6 days after randomization.
Time frame: 6 days
Number of patients with cerebrovascular events, cardiovascular events or death.
Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage. Cardiovascular events included angina and myocardial infarction. Death included any reason caused death.
Time frame: 1 year
Proportion of patients with any side effects of Remote ischemic conditioning (RIC) treatment.
The side effects referred to any side effects of RIC or sham RIC treatment, not including the sides effect of medications and Carotid Endarterectomy (CEA).
Time frame: 6 days
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