Moyamoya Disease
Conditions
Keywords
moyamoya disease, remote ischemic conditioning, cerebral blood flow
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.
Interventions
DEVICERIC
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.
DRUGAspirin
patients will accept medication guided by neurologists
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| improvement ratio of mean cerebral blood flow | change from the baseline to12 months after treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of transient ischemic attack | from the baseline to 12 months after treatment | TIA is diagnosed by patients' transient neurologic deficit |
| incidence of hemorrhagic stroke | from the baseline to 12 months after treatment | hemorrhagic stroke is diagnosed by head CT |
| The level of matrix metalloproteinase 9 (MMP-9) | change from the baseline to 3, 6, 12 months after treatment | 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 |
| The level of vascular endothelial growth factor | change from the baseline to 3, 6, 12 months after treatment | 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 |
| incidence of ischemic stroke | from the baseline to 12 months after treatment | ischemic stroke is diagnosed by symptoms of neurologic deficit or head CT and MRI. |
| The rate of death and adverse event | change from the baseline to 12 months after treatment | All causes of death will be included to compute mortality at 12 months after therapy |
| The number of patients with erythema,and/or skin lesions related to RIC | change from the baseline to 12 months after treatment | Professional doctors will check it and the investigator will record the number. |
| The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure | change from the baseline to 12 months after treatment | the investigator will record the number. |
| The rate of progression of stenosis or occlusion at Willis circle | 12 months after therapy | 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. |
| The level of basic fibroblast growth factor | change from the baseline to 3, 6 ,12 months after treatment | 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 |
Countries
China
Outcome results
None listed