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The overall incidence of DWI positive for thromboembolic events following endovascular treatment of intracranial aneurysms is proximately 50%. Whether remote ischemic conditioning was safe and effective to reduce ischemic brain lesions on DWI after endovascular treatment of intracranial aneurysms is still unclear. The investigators' hypothesis is that remote ischemic conditioning is a safe and effective strategy to reduce new ischemic lesions in intracranial aneurysms patients undergoing endovascular treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote ischemic conditioning group | Experimental |
| |
| Sham remote ischemic conditioning group | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| remote ischemic conditioning | Device | Remote ischemic conditioning is performed by using an electric autocontrol device with cuffs that inflated to a pressure of 200 mm Hg during the ischemic period (Patent No. CN200820123637.X, China) |
| Measure | Description | Time Frame |
|---|---|---|
| The presence of ≥1 new brain lesions on DWI | Assessed by DWI | within 72 hours after endovascular treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of new ischemic lesions | within 72 hours after endovascular treatment | |
| Volume of new ischemic lesions | within 72 hours after endovascular treatment | |
| National Institutes of Health Stroke Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events and serious adverse events | Occurrence of adverse events and serious adverse events | 30 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xunming Ji, MD | Contact | 008601083198930 | jixm@ccmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | 100053 | China |
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| ID | Term |
|---|---|
| D017542 | Aneurysm, Ruptured |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| sham remote ischemic conditioning | Device | Sham remote ischemic conditioning is performed by using an electric autocontrol device with cuffs that inflated to a pressure of 60 mm Hg |
|
Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits. |
| 7 days or discharge |
| Composite of Cerebrovascular events | This is a composited endpoint.Cerebrovascular events included ischemic stroke, hemorrhagic stroke, and TIA. The present subarachnoid hemorrhage isn't included. | 30 days |
| Nondisabling events | Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits.National Institutes of Health Stroke Scale ≤3 or TIA is defined as nondisabling events The present subarachnoid hemorrhage isn't included. | 30 days |
| Modified Rankin Scale | Scores on the modified Rankin scale of functional disability range from 0 (no symptoms) to 6 (death). | 30 days |
| Shengli Oilfield Central Hospital | Recruiting | Dongying | Shandong | China |
|
| The Second People's Hospital of Liaocheng | Recruiting | Liaocheng | China |
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| Nanyang City Center Hospital | Recruiting | Nanyang | China |
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| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | China |
|