Clinical trial NCT03821181: The Effect of RIC on TIA/Stroke in Children With Moyamoya Disease
Official title: Remote Ischemic Conditioning Prevents Ischemic Cerebrovascular Events In Children With Moyamoya Disease: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Moyamoya Disease
TIA
Children
Stroke
Keywords: pediatric moyamoya disease
TIA
Stroke
Remote ischemic conditioning
Lead sponsor: Capital Medical University
Sponsor class: OTHER
Collaborators: name: 307 Hospital of PLA
First posted: 2019-01-29
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The incidence rate of transient ischemic attack(TIA)
timeFrame: during baseline to 12months after therapy
measure: The incidence rate of ischemic stroke
timeFrame: during baseline to 12months after therapy
Secondary outcomes:
measure: Cerebral perfusion
timeFrame: change from baseline to 12months after therapy
measure: The mean blood flow velocity of cerebral vascular detected by TCCD
timeFrame: changes form baseline to 6months，12months after therapy
measure: The score of National Institute of Health stroke scale score
timeFrame: during baseline to 12months after therapy
measure: The score of Modified Rankin scale score
timeFrame: during baseline to 12months after therapy
measure: Incidence rate of symptomatic intracerebral hemorrhage
timeFrame: during baseline to 12months after therapy
measure: The number of cerebral lacunar infarction
timeFrame: changes from baseline to 12months after therapy
measure: The volume of cerebral lacunar infarction
timeFrame: changes from baseline to 12 months after therapy
measure: The rate of death and adverse event
timeFrame: during baseline to 12months after therapy
measure: Number of distal radial pulses
timeFrame: changes from baseline to 6, 12months after therapy
measure: Visual inspection of local edema of fundus oculi
timeFrame: changes from baseline to 6, 12months after therapy
measure: The number of patients with erythema,and/or skin lesions related to RIC
timeFrame: changes from baseline to 6, 12months after therapy
measure: Palpation for tenderness
timeFrame: changes from baseline to 6, 12months after therapy
measure: The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure
timeFrame: during baseline to 12months after therapy
measure: The number of patients with any other adverse events related to RIC intervention
timeFrame: during baseline to 12months after therapy
measure: The score of ABCD2
timeFrame: during baseline to 12months after therapy
measure: The level of S-100A4
timeFrame: change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy
measure: The level of matrix metalloproteinase 9 (MMP-9)
timeFrame: change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy
measure: The level of basic fibroblast growth factor
timeFrame: change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy
measure: The level of platelet derived growth factor
timeFrame: change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy
measure: The level of vascular endothelial growth factor
timeFrame: change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy
measure: The level of hs-CRP(high-sensitive C-reactive protein)
timeFrame: change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy
measure: cerebral perfusion examined by SPECT
timeFrame: from baseline（pre-RIC treatment) to 12 months after therapy
measure: cerebral perfusion examined by ASL
timeFrame: from baseline（pre-RIC treatment) to 12 months after therapy
measure: variant of the RNF-213 gene
timeFrame: from baseline（pre-RIC treatment) to 12 months after therapy
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
Study officials:
References: