Clinical trial NCT04917003: Safety and Efficacy of Remote Ischemic Conditioning Combined EDAS on Ischemic Moyamoya Disease
Official title: Safety and Efficacy of Remote Ischemic Conditioning Combined Encephaloduroarteriosynangiosis（EDAS）on Ischemic Moyamoya Disease: A Prospective, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Moyamoya Disease
Keywords: moyamoya disease
EDAS
remote ischemic conditioning
cerebral blood flow
Lead sponsor: Capital Medical University
Sponsor class: OTHER
Collaborators: name: Beijing 302 Hospital
First posted: 2021-06-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: rCBF changed ratio at operative side
timeFrame: From baseline to 3 months.
Secondary outcomes:
measure: the change of TTP delay at operative side
timeFrame: From baseline to 3 months.
measure: rCBF changed ratio at non-operative side
timeFrame: From baseline to 3 months.
measure: the change of TTP delay at non-operative side
timeFrame: From baseline to 3 months.
measure: Incidence of major adverse cerebral event ( MACE)
timeFrame: From baseline to 3 months.
measure: The change of luminal area of superficial temporal artery
timeFrame: From baseline to 3 months.
measure: The degree of the collaterals from superficial temporal artery
timeFrame: From baseline to 3 months.
measure: Volume of regions with hyperintense signal
timeFrame: From baseline to 3 months.
measure: Number of regions with hyperintense signal
timeFrame: From baseline to 3 months.
measure: RIC related Adverse events
timeFrame: From baseline to 3 months.
measure: Flow velocity of superficial temporal artery at operative side
timeFrame: From baseline to 3 months.
Other outcomes:
Locations:
city: Beijing
country: China
facility: The 307th Hospital of the Chinese People's Liberation Army
Study officials:
References: