Safety and Efficacy of Remote Ischemic Conditioning Combined EDAS on Ischemic Moyamoya Disease (RIC-IMD)

Capital Medical University

Status: Unknown

Conditions: Moyamoya Disease

Treatments: Other: EDAS; Other: RIC plus EDAS

Study type: Interventional

Funder types: Other

Identifiers

NCT04917003

RIC-IMD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

RIC group

Experimental group

Description:

Patients who are allocated into RIC group will undergo the first EDAS surgery combined 3-month remote ischemic conditioning (RIC) treatment. The opposite operation will be performed at 3 months after the first operation. RIC is a non-invasive therapy that performed by an electric auto-control device with cuff placed on arm. RIC procedures consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on one arm. EDAS involves placement of an external carotid artery branch beneath the dura in the ischemic territories. The superficial temporal artery (STA) was commonly used.

Treatment:

Other: RIC plus EDAS

control group

Other group

Description:

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. EDAS involves placement of an external carotid artery branch beneath the dura in the ischemic territories. The superficial temporal artery (STA) was commonly used. Under certain circumstances, depending on the territory at risk, the occipital artery was also used. The donor vessel with the strip of galea (the arterial bridge) was detached from the pericranium or the fascia below, and two burr holes are made beneath the proximal and distal ends of the arterial bridge. The burr holes, with an average size of 3.0 × 8.0 cm, were connected by mill to make an oval bone flap and the dura was exposed. The target artery was then sewn to the dura using 10-0 Prolene suture. The bone flap was closed after cutting out the entry and exit sites for the target artery.

Treatment:

Other: EDAS