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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.
In this study, 60 patients with internal carotid artery occlusion receiving hybird surgery are included in our center in China. The experimental group will receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times per day for 6 consecutive days. The control group will 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 90 days to evaluate the safety and efficacy of remote ischemic conditioning in patients with internal carotid artery occlusion receiving hybird surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIC | Active Comparator | 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 inflation of a blood pressure cuff to 200 mmHg. RIC will be conducted twice daily for 6 consecutive days after enrollment. |
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| Sham RIC | Placebo Comparator | Sham 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 inflation of a blood pressure cuff to 60 mmHg. Sham RIC will be conducted twice daily for 6 consecutive days after enrollment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischemic conditioning | Device | Remote 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 days |
| The volume of new Diffusion Weighted Imaging (DWI)-positive lesions on post-treatment magnetic resonance imaging (MRI) Scans. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Yang, MD, PhD | Contact | 0086-13756661217 | doctor_yangyi@163.com | |
| Zhenni Guo, MD, PhD | Contact | zhen1ni2@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi Yang, MD, PhD | Neuroscience Center, Department of Neurology, The First Hospital of Jilin University | Study Chair |
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| Sham remote ischemic conditioning | Device | Sham 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. |
|
Patients will undergo magnetic resonance imaging(including DWI) at baseline and 6 days after randomization. |
| 6 days |
| 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. | 90±7 days |
| 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. | 6 days |
| Proportion of patients with any adverse events(including serious adverse events) | Adverse events due to any cause after enrollment of subjects in both groups. | 90±7 days |