Effects of Remote Ischemic Pre-Conditioning on Neurologic Complications in Adult Ischemic Moyamoya Disease Patients Undergoing Encephaloduroarteriosynangiosis
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 328
- 试验地点
- 2
- 主要终点
- Number of Patients Dependent or Death
研究概览
简要总结
In the present study, investigators evaluated whether RIPC reduce the major neurological complications in adult moyamoya disease patients undergoing encephaloduroarteriosynangiosis (EDAS).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who diagnosed with moyamoya disease
- •Adults 18 to 65 years of age
- •The onset symptoms manifested as ischemic symptoms (TIA or stroke) or atypical symptoms (headache, epilepsy or asymptomatic)
- •Able to receive the necessary imaging examination
- •Patients who pre-agreed to the study
排除标准
- •Prior cerebral hemorrhage history
- •Other brain or cerebrovascular disease
- •Previous history of revascularization surgery
- •Dependent (mRS > 2)
- •Receive other type of revascularization surgery
- •Peripheral blood vessel disease (especially subclavian arterial and upper limb artery stenosis or occlusion).
- •Patients who do not agree with the study
研究组 & 干预措施
Sham RIPC group
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
干预措施: Sham remote ischemic preconditioning (Procedure)
Sham RIPC group
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
干预措施: Encephaloduroarteriosynangiosis (Procedure)
RIPC group
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
干预措施: Remote ischemic preconditioning (Procedure)
RIPC group
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
干预措施: Encephaloduroarteriosynangiosis (Procedure)
结局指标
主要结局
Number of Patients Dependent or Death
时间窗: postoperative one month
Dependent included the modified Rankin Scale (mRS) \> 2. Death included any reason caused death.
Number of Patients With Cerebrovascular Events.
时间窗: postoperative one month
Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and hyperperfusion syndrome.
次要结局
- Number of Patients Dependent or Death at Follow-up Period(6 months and 12 months after EDAS)
- The Severity of the Ischemic Stroke after Surgery(postoperative one month)
- Number of Patients With Any Side Effects of Remote Ischemic Preconditioning (RIPC) Treatment.(From baseline to 12 months after treatment)
- Number of Patients Occured Re-stroke at Follow-up Period(6 months and 12 months after EDAS)
- Number of Patients with Improved Neurological Function at Follow-up Period(6 months and 12 months after EDAS)
- Perfusion Status of Patients at Follow-up Period(6 months and 12 months after EDAS)
- Participants Who Got New Diffusion-weighted Imaging (DWI) Lesions on Post-treatment Magnetic Resonance Imaging (MRI) Scans.(Within 48 hours after EDAS)
研究者
yuanli Zhao
Professor
Beijing Tiantan Hospital