Encephaloduroarteriosynangiosis (EDAS) is widely used as an indirect technique for treatment of moyamoya disease. Nevertheless, this indirect surgery tends to establish insufficient collateral circulation in most adult MMD patients. Nowadays, there is a lack of adjuvant therapies for improving collateral circulation induced by indirect revascularization. This study aims to explore whether remote ischemic conditioning can improve the collateral circulation after indirect revascularization.
Encephaloduroarteriosynangiosis (EDAS) is widely used as an indirect technique for treatment of moyamoya disease. Nevertheless, this indirect surgery tends to establish insufficient collateral circulation in most adult MMD patients. Nowadays, there is a lack of adjuvant therapies for improving collateral circulation induced by indirect revascularization. Remote ischemic conditioning (RIC) is a noninvasive approach protecting the brain by inflating and deflating blood-pressure cuff placed on the upper limbs. It has been confirmed to improve cerebral perfusion by promoting angiogenesis and arteriogenesis in ischemic animal brain. In addition, daily remote ischemic conditioning is a promising technique to ameliorate chronic cerebrovascular disease like intracranial atherosclerotic stenosis, small-vessel disease. Thus, this study aims to explore whether remote ischemic conditioning can improve the collateral circulation after indirect revascularization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Patients who are allocated into RIC group will undergo EDAS surgery combined 3-month RIC treatment. The opposite operation will be performed at 3 months after the first operation.
Patients who are allocated into the control group will accept EDAS surgery twice. The second operation will be performed at 3 months after the first operation.
The 307th Hospital of the Chinese People's Liberation Army
Beijing, China
RECRUITINGrCBF changed ratio at operative side
Cerebral blood flow will be evaluated by dynamic susceptibility contrast-MRI examination，and relative cerebral blood flow(rCBF) changed ratio will be calculated by the formula: (rCBF in MCA territory/rCBF in cerebellum after treatment - rCBF in MCA territory/rCBF in cerebellum before treatment )/ rCBF in MCA territory/rCBF in cerebellum before treatment (the operative side). The higher value of rCBF improvement ratio means better imaging outcome.
Time frame: From baseline to 3 months.
the change of TTP delay at operative side
Time to peak(TTP) will be evaluated by dynamic susceptibility contrast-MRI examination. The improvement of TTP delay at operative side will be calculated by the formula: the change of TTP delay =TTP delay in MCA territory before treatment - TTP delay in MCA territory after treatment (the operative side). The higher value means better imaging outcome.
Time frame: From baseline to 3 months.
rCBF changed ratio at non-operative side
Cerebral blood flow will be evaluated by dynamic susceptibility contrast-MRI examination，and relative cerebral blood flow(rCBF) changed ratio will be calculated by the formula: (rCBF in MCA territory/rCBF in cerebellum after treatment - rCBF in MCA territory/rCBF in cerebellum before treatment )/ rCBF in MCA territory/rCBF in cerebellum before treatment (the non-operative side). The higher value of rCBF improvement ratio means better imaging outcome.
Time frame: From baseline to 3 months.
the change of TTP delay at non-operative side
Time to peak(TTP) will be evaluated by dynamic susceptibility contrast-MRI examination. The improvement of TTP delay at non-operative side will be calculated by the formula: Improvement of TTP delay =TTP delay in MCA territory before treatment - TTP delay in MCA territory after treatment (the non-operative side). The higher value means better imaging outcome.
Time frame: From baseline to 3 months.
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Incidence of major adverse cerebral event ( MACE)
MACE contains ischemic or hemorrhagic stroke, crescendo TIAs evaluated by registered Neurologists.
Time frame: From baseline to 3 months.
The change of luminal area of superficial temporal artery
The luminal area of STA can reflect the angiogenesis induced by EDAS to some extent, and it will be measured by TOF-MRA.
Time frame: From baseline to 3 months.
The degree of the collaterals from superficial temporal artery
The degree of the collaterals from superficial temporal artery will be evaluated by Transcranial Doppler ultrasound performed by an experienced technician. 0 for no collaterals from STA, 1 for little collaterals from STA, 2 for good collaterals from STA .
Time frame: From baseline to 3 months.
Volume of regions with hyperintense signal
Volume of regions with hyperintense signal where the maximum dimension should be larger than 8mm will be measured at axial T2, fluid-attenuated inversion recovery.
Time frame: From baseline to 3 months.
Number of regions with hyperintense signal
Number of regions with hyperintense signal will be counted at axial T2, fluid-attenuated inversion recovery.
Time frame: From baseline to 3 months.
RIC related Adverse events
Adverse events related to RIC treatment, such as local edema, erythema, skin lesions of the arms.
Time frame: From baseline to 3 months.
Flow velocity of superficial temporal artery at operative side
Flow velocity of superficial temporal artery at operative side will be evaluated by Transcranial Doppler ultrasound performed by an experienced technician.
Time frame: From baseline to 3 months.