Moyamoya Disease
Conditions
Keywords
moyamoya disease, EDAS, remote ischemic conditioning, cerebral blood flow
Brief summary
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.
Detailed description
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.
Interventions
OTHERRIC plus EDAS
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.
OTHEREDAS
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.
Sponsors
Beijing 302 Hospital
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects who were diagnosed as moyamoya disease by the diagnostic criteria recommended by the Research Committee on MMD of the Ministry of Health and Welfare of Japan in 2012. 2. Suzuki stage: 2-5 stage 3. Age: between 18 and 65 years old 4. Subjects present with ischemic stroke or transient ischemic attack. 5. Subjects who plan to accept the first EDAS surgery. 6. Informed consent obtained from patient or patient's surrogate
Exclusion criteria
1. Acute ischemic stroke occurred within one month. 2. Suffered Intracranial hemorrhage before 3. Subjects with large infarction spread widely over the territory of a main arterial trunk 4. Aneurysms in the main arterial trunk 5. Severe cardiac diseases like atrial fibrillation，valvular disease，heart failure, infective endocarditis and so on. 6. Malignant tumors or severe disordered function of the heart, lung, liver or kidney. 7. Severe hemostatic disorder or severe coagulation dysfunction. 8. Uncontrolled diabetes mellitus with a serum fasting blood glucose level\>300 mg/dL, or requires insulin; hypertension with a systolic blood pressure over 180 mmHg or a diastolic blood pressure over 110 mmHg. 9. Severe injury on upper limbs. 10. Pregnant or lactating women. 11. Life expectancy is less than 3 years. 12. Patients who are not suitable for this trial considered by researchers for other reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rCBF changed ratio at operative side | From baseline to 3 months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rCBF changed ratio at non-operative side | From baseline to 3 months. | 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. |
| the change of TTP delay at non-operative side | From baseline to 3 months. | 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. |
| Incidence of major adverse cerebral event ( MACE) | From baseline to 3 months. | MACE contains ischemic or hemorrhagic stroke, crescendo TIAs evaluated by registered Neurologists. |
| The change of luminal area of superficial temporal artery | From baseline to 3 months. | The luminal area of STA can reflect the angiogenesis induced by EDAS to some extent, and it will be measured by TOF-MRA. |
| the change of TTP delay at operative side | From baseline to 3 months. | 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. |
| Volume of regions with hyperintense signal | From baseline to 3 months. | 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. |
| Number of regions with hyperintense signal | From baseline to 3 months. | Number of regions with hyperintense signal will be counted at axial T2, fluid-attenuated inversion recovery. |
| RIC related Adverse events | From baseline to 3 months. | Adverse events related to RIC treatment, such as local edema, erythema, skin lesions of the arms. |
| Flow velocity of superficial temporal artery at operative side | From baseline to 3 months. | Flow velocity of superficial temporal artery at operative side will be evaluated by Transcranial Doppler ultrasound performed by an experienced technician. |
| The degree of the collaterals from superficial temporal artery | From baseline to 3 months. | 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 . |
Countries
China
Contacts
Primary ContactXunming Ji, PhD
Backup ContactJiali Xu, MD
Outcome results
None listed