The Safety and Efficacy of RIC on Adult Moyamoya Disease (RIC-AMD)

Capital Medical University

Status: Completed

Conditions: Moyamoya Disease

Treatments: Drug: Aspirin; Device: RIC

Study type: Interventional

Funder types: Other

Identifiers

NCT04012268

RIC-AMD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

RIC group

Experimental group

Description:

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. They will also accept medication treatment by professional neurologists.

Treatment:

Device: RIC

Medication group

Other group

Description:

Patients allocated to Medication group will accept medication treatment by professional neurologists.

Treatment:

Drug: Aspirin