The Safety and Effect of Remote Ischemic Conditioning on Adult Moyamoya Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- improvement ratio of mean cerebral blood flow
研究概览
简要总结
There are a series of symptoms such as ischemic stroke、transient ischemic attack 、hemorrhagic stroke、headache 、seizure and so on in moyamoya disease( MMD) patients .Nowadays, revascularization is the only effective way for ischemic MMD and there is no effective conservative treatment for MMD. This study was to explore the safety and efficacy of remote ischemic conditioning(RIC ) on adult MMD patients.
详细描述
There are a series of symptoms such as ischemic stroke、transient ischemic attack 、hemorrhagic stroke、headache 、seizure and so on in moyamoya disease. Nowadays, revascularization is the only effective way for ischemic MMD while controversial for hemorrhagic MMD patients. Surgical complications including hyperperfusion syndrome, cerebral infarction or bleeding often occurred postoperatively. There is no effective conservative treatment for MMD up to now.
Remote ischemic conditioning is Remote ischemic conditioning (RIC) is a noninvasive and easy-to-use neuroprotective strategy, and it has potential effects on preventing ischemia reperfusion injury and ischemic infarction.This study was to explore the safety and efficacy of remote ischemic conditioning on adult MMD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-60 years
- •All of the patients underwent digital subtraction angiography (DSA) and met the current diagnostic criteria recommended by the Research Committee on MMD of the Ministry of Health and Welfare of Japan in
- •Informed consent obtained from patient or acceptable patient's surrogate.
排除标准
- •Patients with acute ischemic or hemorrhagic stroke within 3 months.
- •Severe hepatic or renal dysfunction.
- •Severe hemostatic disorder or severe coagulation dysfunction.
- •Severe cardiac diseases.
- •Patients with severe existing neurological or psychiatric disease
- •Patients with moyamoya syndrome caused by autoimmune disease, Down syndrome , neurofibromatosis, leptospiral infection, or previous skull-base radiation therapy.
- •Patients have been done or plan to accept revascularization surgery.
研究组 & 干预措施
RIC group
Patients allocated to the RIC group will undergo RIC procedure during which bilateral arm cuffs are inflated to a pressure of 50 mmHg over systolic blood pressure for five cycles of 5 min followed by 5 min of relaxation of the cuffs. They will also accept medication treatment by professional neurologists.
干预措施: RIC (Device)
Medication group
Patients allocated to Medication group will accept medication treatment by professional neurologists.
干预措施: Aspirin (Drug)
结局指标
主要结局
improvement ratio of mean cerebral blood flow
时间窗: change from the baseline to12 months after treatment
Cerebral blood flow refers to the flow of blood through a certain cross-sectional area of cerebrovascular in a unit time. Patients' CBF will be detected by arterial spin labeling. In each hemisphere, middle cerebral artery territory was divided into ten regions according to Albert Stroke Program Early CT score (ASPECTS), regions of interest (ROI) were drawn manually in each of territory of MCA to determine the absolute CBF values. improvement ratio of mean CBF= mCBF atter treatment-mCBF baseline/mCBF baseline.
次要结局
- The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure(change from the baseline to 12 months after treatment)
- The number of patients with erythema,and/or skin lesions related to RIC(change from the baseline to 12 months after treatment)
- incidence of ischemic stroke(from the baseline to 12 months after treatment)
- incidence of transient ischemic attack(from the baseline to 12 months after treatment)
- The level of matrix metalloproteinase 9 (MMP-9)(change from the baseline to 3, 6, 12 months after treatment)
- The level of vascular endothelial growth factor(change from the baseline to 3, 6, 12 months after treatment)
- The level of basic fibroblast growth factor(change from the baseline to 3, 6 ,12 months after treatment)
- The rate of progression of stenosis or occlusion at Willis circle(12 months after therapy)
- incidence of hemorrhagic stroke(from the baseline to 12 months after treatment)
- The rate of death and adverse event(change from the baseline to 12 months after treatment)
研究者
Ji Xunming,MD,PhD
Professor
Capital Medical University