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waiting for the ethics approval of collaborator affiliation
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| Name | Class |
|---|---|
| Peking University International Hospital | OTHER |
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In the present study, investigators evaluated whether RIPC reduce the major neurological complications in adult moyamoya disease patients undergoing encephaloduroarteriosynangiosis (EDAS).
BACKGROUND: Brain ischemia and injury contributed to perioperative morbidity and mortality in revascularization surgery. Remote ischemic preconditioning (RIPC), brief periods of ischemia followed by reperfusion, can provide systemic protection for prolonged ischemia. Previous study found combined remote ischemic pre- and post-conditioning can be effective in reducing neurologic complications and the duration of hospitalization in moyamoya patients undergoing direct revascularization.In order to investigate whether RIPC before EDAS can protect these patients from the perioperative and long-term complications, a prospective randomized controlled trial will be performed in the current study.
DESIGNING: About 328 patients who are eligible for carotid artery stenting will be randomly assigned in 1:1 ratio to RIPC group and sham RIPC group (control). Remote limb ischemic preconditioning (RIPC) is consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, it is induced by a sphygmomanometer placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min, patients in the RIPC group will do it twice a day for at least five days before EDAS. Patients in the sham RIPC group receive sham RIPC treatment, which is consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, induced by a sphygmomanometer placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min, they will do it twice a day for at least five days before EDAS. Cerebral injury is assessed by plasma Human Soluble protein-100B (S-100B) and Neuron specific enolase (NSE). Clinical outcomes are determined by cerebrovascular events (including ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and transient neurological deficit) and death or dependent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham RIPC group | Sham Comparator | Treatment:Patients in this group received standard medical therapy and sham remote ischemic preconditioning treatment. Device:Sham RIPC consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by a sphygmomanometer placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min, each patient in Sham RIPC group do it twice a day for at least five days before encephaloduroarteriosynangiosis. Procedure: Encephaloduroarteriosynangiosis |
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| RIPC group | Experimental | Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment. Device:RIPC consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by a sphygmomanometer placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min,each patient in the RIPC group do it twice a day for at least five days before encephaloduroarteriosynangiosis. Procedure: Encephaloduroarteriosynangiosis |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischemic preconditioning | Procedure | Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by a sphygmomanometer placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Cerebrovascular Events. | Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and hyperperfusion syndrome. | postoperative one month |
| Number of Patients Dependent or Death | Dependent included the modified Rankin Scale (mRS) > 2. Death included any reason caused death. | postoperative one month |
| Measure | Description | Time Frame |
|---|---|---|
| The Severity of the Ischemic Stroke after Surgery | The severity of the ischemic stroke was evaluated by the white matter hyperintensities volume on the MRI, the neurological deficits duration and the Modified Rankin Scale (mRS) of patients. | postoperative one month |
| Number of Patients Occured Re-stroke at Follow-up Period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuanli Zhao, MD | Beijing Tiantan Hospital | Principal Investigator |
| Rong Wang, MD | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hosiptal | Beijing | Beijing Municipality | 100070 | China | ||
| Peking University International Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36645250 | Derived | Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3. |
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The individual participant data (IPD) of this study are available from the principal investigator upon reasonable request.
6 months after the study ended
The IPD of this study are available from the principal investigator upon reasonable request.
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| ID | Term |
|---|---|
| D009072 | Moyamoya Disease |
| D002561 | Cerebrovascular Disorders |
| D001157 | Arterial Occlusive Diseases |
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Sham remote ischemic preconditioning | Procedure | Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by a sphygmomanometer placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min. |
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| Encephaloduroarteriosynangiosis | Procedure | Encephaloduroarteriosynangiosis is an indirect revascularization surgery of moyamoya disease |
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Re-stroke included ischemic stroke and hemorrhagic stroke. |
| 6 months and 12 months after EDAS |
| Number of Patients Dependent or Death at Follow-up Period | Dependent included the modified Rankin Scale (mRS) > 2. Death included any reason caused death. | 6 months and 12 months after EDAS |
| Number of Patients with Improved Neurological Function at Follow-up Period | The modified Rankin Scale (mRS) decreased at the follow-up period compared to preoperative scores | 6 months and 12 months after EDAS |
| Perfusion Status of Patients at Follow-up Period | The perfusion status detected by stages of pre-infarction period based on computed tomography perfusion imaging | 6 months and 12 months after EDAS |
| Number of Patients With Any Side Effects of Remote Ischemic Preconditioning (RIPC) Treatment. | The side effects referred to any side effects of RIPC or sham RIPC treatment, not including the sides effect of medications and EDAS. | From baseline to 12 months after treatment |
| Participants Who Got New Diffusion-weighted Imaging (DWI) Lesions on Post-treatment Magnetic Resonance Imaging (MRI) Scans. | The presence of ≥1 new brain lesions on DWI | Within 48 hours after EDAS |
| Beijing |
| Beijing Municipality |
| 102206 |
| China |
| D002539 | Cerebral Arterial Diseases |
| D020765 | Intracranial Arterial Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |