Remote Ischemic Conditioning Prevents Ischemic Cerebrovascular Events In Children With Moyamoya Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The incidence rate of transient ischemic attack(TIA)
研究概览
简要总结
Moyamoya disease is a common reason of transient ischemic attack (TIA) and stroke in children. Remote ischemic conditioning (RIC) has been shown to prevent recurrent stroke in intracranial arterial stenosis, but it is unclear whether RIC can prevent TIA or stroke in children with moyamoya disease. This study aims to evaluate the effect of RIC on TIA/stroke in children with moyamoya disease.
详细描述
This study will provide insights into the preliminary proof of principle, safety, and efficacy of RIC in pediatric MMD patients, and this data will provide parameters for future larger scale clinical trials if efficacious
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: ≥0 and ≤18
- •all of the patients underwent digital subtraction angiography and met the current diagnostic criteria recommended by the Research Committee on MMD (Spontaneous Occlusion of the Circle of Willis) of the Ministry of Health and Welfare of Japan in 2012
- •The CVR of patients detected by SPECT is not impaired severely
- •The patients didn't suffer stroke before.
- •Informed consent obtained from patient or acceptable patient's surrogate
排除标准
- •Severe hepatic or renal dysfunction
- •Severe hemostatic disorder or severe coagulation dysfunction
- •Patients with unilateral MMD or the presence of secondary moyamoya phenomenon caused by autoimmune disease, Down syndrome, neurofibromatosis, leptospiral infection, or previous skull-base radiation therapy
- •Any of the following cardiac disease - rheumatic mitral and or aortic stenosis, prosthetic heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, patent foramen ovale, left ventricular mural thrombus or valvular vegetation, congestive heart failure, bacterial endocarditis, or any other cardiovascular condition interfering with participation
- •Serious, advanced, or terminal illnesses with anticipated life expectancy of less than one year
- •Patient participating in a study involving other drug or device trial study
- •Patients with existing neurological or psychiatric disease that would confound the neurological or functional evaluations
- •Unlikely to be available for follow-up for 3 months
- •Contraindication for RIC - severe soft-tissue injury, fracture, or peripheral vascular disease in the upper limbs.
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.
干预措施: RIC group (Device)
sham group
patients allocated to the sham group will undergo a sham RIC procedure during which bilateral arm cuffs are inflated to a pressure of 30 mmHg for five cycles of 5 min, followed by 5 min of relaxation of the cuffs.
干预措施: Sham group (Device)
结局指标
主要结局
The incidence rate of transient ischemic attack(TIA)
时间窗: during baseline to 12months after therapy
TIA means transient ischemic attack, two neurologists will evaluate patients with ischemic symptoms and make diagnosis.magnetic reasoning imaging (MRI) scan will be performed to confirm intracerebral hemorrhage, and the imaging will be evaluated by two independent neuroradiologists who are blinded to the study assignment.
The incidence rate of ischemic stroke
时间窗: during baseline to 12months after therapy
Two neurologists will evaluate patients with ischemic symptoms and make diagnosis.magnetic reasoning imaging (MRI) scan will be performed to confirm intracerebral hemorrhage, and the imaging will be evaluated by two independent neuroradiologists who are blinded to the study assignment.
次要结局
- Palpation for tenderness(changes from baseline to 6, 12months after therapy)
- The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure(during baseline to 12months after therapy)
- The score of National Institute of Health stroke scale score(during baseline to 12months after therapy)
- Cerebral perfusion(change from baseline to 12months after therapy)
- The mean blood flow velocity of cerebral vascular detected by TCCD(changes form baseline to 6months，12months after therapy)
- Incidence rate of symptomatic intracerebral hemorrhage(during baseline to 12months after therapy)
- The rate of death and adverse event(during baseline to 12months after therapy)
- The number of patients with erythema,and/or skin lesions related to RIC(changes from baseline to 6, 12months after therapy)
- The number of patients with any other adverse events related to RIC intervention(during baseline to 12months after therapy)
- The level of matrix metalloproteinase 9 (MMP-9)(change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy)
- The score of Modified Rankin scale score(during baseline to 12months after therapy)
- The number of cerebral lacunar infarction(changes from baseline to 12months after therapy)
- Number of distal radial pulses(changes from baseline to 6, 12months after therapy)
- The score of ABCD2(during baseline to 12months after therapy)
- variant of the RNF-213 gene(from baseline（pre-RIC treatment) to 12 months after therapy)
- The volume of cerebral lacunar infarction(changes from baseline to 12 months after therapy)
- Visual inspection of local edema of fundus oculi(changes from baseline to 6, 12months after therapy)
- The level of S-100A4(change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy)
- cerebral perfusion examined by ASL(from baseline（pre-RIC treatment) to 12 months after therapy)
- The level of hs-CRP(high-sensitive C-reactive protein)(change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy)
- The level of basic fibroblast growth factor(change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy)
- The level of platelet derived growth factor(change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy)
- The level of vascular endothelial growth factor(change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy)
- cerebral perfusion examined by SPECT(from baseline（pre-RIC treatment) to 12 months after therapy)
研究者
Ji Xunming,MD,PhD
Professor
Capital Medical University