Safety and Efficacy of Remote Ischemic Conditioning in Pediatric Moyamoya Disease Patients Treated With Revascularization Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- the incidence of major neurologic complications
研究概览
简要总结
Revascularization surgery has been the standard treatment to prevent ischemic stroke in pediatric Moyamoya disease (MMD) patients with ischemic symptoms. However, perioperative complications, such as hyperperfusion syndrome, new infarct on imaging, or ischemic stroke, are inevitable. Remote ischemic conditioning (RIC) is a noninvasive and easy-to-use neuroprotective strategy, and it has potential effects on preventing hyperperfusion syndrome and ischemic infarction.
详细描述
This study will provide insights into the preliminary proof of principle, safety, and efficacy of RIC in pediatric MMD patients undergoing revascularization surgery therapy, 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 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
- •Suzuki stages concentrated in Stage III and IV
- •Presentation with ischemic symptoms, such as transient ischemic attack (TIA), headache, seizure, hemorrhagic stroke, and ischemic stroke confirmed by MRI
- •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.They will also accept medication treatment by professional neurologists.
干预措施: RIC group (Device)
Medication group
Patients allocated to the medication group will accept medication treatment by professional neurologists.
干预措施: Medication group (Other)
结局指标
主要结局
the incidence of major neurologic complications
时间窗: during the perioperative period
Including transient ischemic attack, cerebral infarction, intracranial hemorrhage, and seizures.
次要结局
- The score of National Institute of Health stroke scale score(change from baseline (preoperation) at 24 hours, 48 hours, 72 hours, and at 5-7 days or if discharged earlier)
- The score of Modified Rankin scale score(change from baseline (pre-RIC treatment) at 180 days after revascularization therapy)
- Symptomatic intracerebral hemorrhage(during the first 180 days after revascularization therapy)
- Incidence of new infarct in brain(during 72 hours and 180 days after revascularization therapy)
- Angiographic outcome(180 days after revascularization therapy)
- Death and adverse event(180 days after revascularization therapy)
- Infarct volume in brain(during 72 hours and 180 days after revascularization therapy)
- Distal radial pulses(within 7 days after RIC treatment)
- Visual inspection for local edema(within 7days after RIC treatment)
- The number of patients with erythema,and/or skin lesions related to RIC(within 7days after RIC treatment)
- Palpation for tenderness(within 7days after RIC treatment)
- The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure(within 7days after RIC treatment)
- The number of patients with any other adverse events related to RIC intervention(within 7days after RIC treatment)
- The score of ABCD2(change from baseline (pre-RIC treatment) at 180 days after revascularization therapy)
- The level of S-100A4(change from baseline (pre-RIC treatment) at 7 days after RIC treatment, 24 (-6/+12) hours, 72 ± 6 hours and 6 months postoperation)
- The level of matrix metalloproteinase 9 (MMP-9)(change from baseline (pre-RIC treatment) at 7 days after RIC treatment, 24 (-6/+12) hours, 72 ± 6 hours and 6 months post-operation)
- The level of basic fibroblast growth factor(change from baseline (pre-RIC treatment) at 7 days after RIC treatment, 24 (-6/+12) hours, 72 ± 6 hours and 6 months post-operation)
- The level of platelet derived growth factor(change from baseline (pre-RIC treatment) at 7 days after RIC treatment, 24 (-6/+12) hours, 72 ± 6 hours and 6 months post-operation)
- The level of vascular endothelial growth factor(change from baseline (pre-RIC treatment) at 7 days after RIC treatment, 24 (-6/+12) hours, 72 ± 6 hours and 6 months post-operation)
- the score of PSQI(0-30 days)
- the score of SNAP-IV(0-30 days)
- cerebral perfusion status(0-3 months)
研究者
Ji Xunming,MD,PhD
Professor
Capital Medical University