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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
30
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.
patients will accept medication guided by neurologists
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
improvement ratio of mean cerebral blood flow
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.
Time frame: change from the baseline to12 months after treatment
incidence of ischemic stroke
ischemic stroke is diagnosed by symptoms of neurologic deficit or head CT and MRI.
Time frame: from the baseline to 12 months after treatment
incidence of transient ischemic attack
TIA is diagnosed by patients' transient neurologic deficit
Time frame: from the baseline to 12 months after treatment
incidence of hemorrhagic stroke
hemorrhagic stroke is diagnosed by head CT
Time frame: from the baseline to 12 months after treatment
The level of matrix metalloproteinase 9 (MMP-9)
Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
Time frame: change from the baseline to 3, 6, 12 months after treatment
The level of vascular endothelial growth factor
Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
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Time frame: change from the baseline to 3, 6, 12 months after treatment
The level of basic fibroblast growth factor
Blood samples will be drawn from cubital vein to test these biomarkersThese samples will be centrifuged immediately after collection and stored at - 80 until batch evaluation
Time frame: change from the baseline to 3, 6 ,12 months after treatment
The rate of death and adverse event
All causes of death will be included to compute mortality at 12 months after therapy
Time frame: change from the baseline to 12 months after treatment
The number of patients with erythema,and/or skin lesions related to RIC
Professional doctors will check it and the investigator will record the number.
Time frame: change from the baseline to 12 months after treatment
The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure
the investigator will record the number.
Time frame: change from the baseline to 12 months after treatment
The rate of progression of stenosis or occlusion at Willis circle
Progression of stenosis or occlusion at Willis circle was evaluated by TOF-MRA, which was defined as the the stenosis or occlusion was progressed to another part of Willis circle, like stenosis progressed from M1 to M2-M4 et al, or in the same part, stenosis progressed to occlusion.
Time frame: 12 months after therapy