Safety and Efficacy of Remote Ischemic Conditioning Combined Encephaloduroarteriosynangiosis（EDAS）on Ischemic Moyamoya Disease: A Prospective, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- rCBF changed ratio at operative side
研究概览
简要总结
Encephaloduroarteriosynangiosis (EDAS) is widely used as an indirect technique for treatment of moyamoya disease. Nevertheless, this indirect surgery tends to establish insufficient collateral circulation in most adult MMD patients. Nowadays, there is a lack of adjuvant therapies for improving collateral circulation induced by indirect revascularization. This study aims to explore whether remote ischemic conditioning can improve the collateral circulation after indirect revascularization.
详细描述
Encephaloduroarteriosynangiosis (EDAS) is widely used as an indirect technique for treatment of moyamoya disease. Nevertheless, this indirect surgery tends to establish insufficient collateral circulation in most adult MMD patients. Nowadays, there is a lack of adjuvant therapies for improving collateral circulation induced by indirect revascularization. Remote ischemic conditioning (RIC) is a noninvasive approach protecting the brain by inflating and deflating blood-pressure cuff placed on the upper limbs. It has been confirmed to improve cerebral perfusion by promoting angiogenesis and arteriogenesis in ischemic animal brain. In addition, daily remote ischemic conditioning is a promising technique to ameliorate chronic cerebrovascular disease like intracranial atherosclerotic stenosis, small-vessel disease.
Thus, this study aims to explore whether remote ischemic conditioning can improve the collateral circulation after indirect revascularization.
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
- Single (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
- •Subjects who were diagnosed as moyamoya disease by the diagnostic criteria recommended by the Research Committee on MMD of the Ministry of Health and Welfare of Japan in
- •Suzuki stage: 2-5 stage
- •Age: between 18 and 65 years old
- •Subjects present with ischemic stroke or transient ischemic attack.
- •Subjects who plan to accept the first EDAS surgery.
- •Informed consent obtained from patient or patient's surrogate
排除标准
- •Acute ischemic stroke occurred within one month.
- •Suffered Intracranial hemorrhage before
- •Subjects with large infarction spread widely over the territory of a main arterial trunk
- •Aneurysms in the main arterial trunk
- •Severe cardiac diseases like atrial fibrillation，valvular disease，heart failure, infective endocarditis and so on.
- •Malignant tumors or severe disordered function of the heart, lung, liver or kidney.
- •Severe hemostatic disorder or severe coagulation dysfunction.
- •Uncontrolled diabetes mellitus with a serum fasting blood glucose level>300 mg/dL, or requires insulin; hypertension with a systolic blood pressure over 180 mmHg or a diastolic blood pressure over 110 mmHg.
- •Severe injury on upper limbs.
- •Pregnant or lactating women.
- •Life expectancy is less than 3 years.
- •Patients who are not suitable for this trial considered by researchers for other reasons
结局指标
主要结局
rCBF changed ratio at operative side
时间窗: From baseline to 3 months.
Cerebral blood flow will be evaluated by dynamic susceptibility contrast-MRI examination，and relative cerebral blood flow(rCBF) changed ratio will be calculated by the formula: (rCBF in MCA territory/rCBF in cerebellum after treatment - rCBF in MCA territory/rCBF in cerebellum before treatment )/ rCBF in MCA territory/rCBF in cerebellum before treatment (the operative side). The higher value of rCBF improvement ratio means better imaging outcome.
次要结局
- RIC related Adverse events(From baseline to 3 months.)
- the change of TTP delay at operative side(From baseline to 3 months.)
- The change of luminal area of superficial temporal artery(From baseline to 3 months.)
- Number of regions with hyperintense signal(From baseline to 3 months.)
- rCBF changed ratio at non-operative side(From baseline to 3 months.)
- the change of TTP delay at non-operative side(From baseline to 3 months.)
- Incidence of major adverse cerebral event ( MACE)(From baseline to 3 months.)
- The degree of the collaterals from superficial temporal artery(From baseline to 3 months.)
- Volume of regions with hyperintense signal(From baseline to 3 months.)
- Flow velocity of superficial temporal artery at operative side(From baseline to 3 months.)
研究者
Ji Xunming,MD,PhD
Professor
Capital Medical University