Clinical trial NCT04012268: The Safety and Efficacy of RIC on Adult Moyamoya Disease
Official title: The Safety and Effect of Remote Ischemic Conditioning on Adult Moyamoya Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Moyamoya Disease
Keywords: moyamoya disease
remote ischemic conditioning
cerebral blood flow
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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 2012.
* mRs≤3
* Informed consent obtained from patient or acceptable patient's surrogate.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: improvement ratio of mean cerebral blood flow
timeFrame: change from the baseline to12 months after treatment
Secondary outcomes:
measure: incidence of ischemic stroke
timeFrame: from the baseline to 12 months after treatment
measure: incidence of transient ischemic attack
timeFrame: from the baseline to 12 months after treatment
measure: incidence of hemorrhagic stroke
timeFrame: from the baseline to 12 months after treatment
measure: The level of matrix metalloproteinase 9 (MMP-9)
timeFrame: change from the baseline to 3, 6, 12 months after treatment
measure: The level of vascular endothelial growth factor
timeFrame: change from the baseline to 3, 6, 12 months after treatment
measure: The level of basic fibroblast growth factor
timeFrame: change from the baseline to 3, 6 ,12 months after treatment
measure: The rate of death and adverse event
timeFrame: change from the baseline to 12 months after treatment
measure: The number of patients with erythema,and/or skin lesions related to RIC
timeFrame: change from the baseline to 12 months after treatment
measure: The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure
timeFrame: change from the baseline to 12 months after treatment
measure: The rate of progression of stenosis or occlusion at Willis circle
timeFrame: 12 months after therapy
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
Study officials:
References: