Remote Ischemic Conditioning in Adult Moyamoya Disease Patients

Fudan University

Status: Not yet enrolling

Conditions: Moyamoya Disease; Remote Ischemic Conditioning

Treatments: Device: Remote ischemic conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT05860946

HS9126

Details and patient eligibility

About

Remote ischemic conditioning (RIC) is a non-invasive therapeutic approach for protecting organs or tissue against the detrimental effects of acute ischemia-reperfusion injury. Many protective factors produced by the stimulus of RIC could protect remote target organs and tissues through inhibiting oxidation and inflammation. The phenomenon of this protect effect was first found in myocardium ischemia-reperfusion injury and then RIC was used in children cardiac surgery to provide myocardial protection during operation. Then RIC was gradually applied to brain protection and a series of clinical researches have confirmed that it could improve the cerebral perfusion status, increase cerebral tolerance to ischemic injury, reduce perihematomal edema and promote clearance. Recently, a randomized controlled study reported that daily RIC could improve cerebral perfusion and slow arterial progression of adult MMD. Meanwhile, a single-arm open-label study also indicated that RIC was a promising noninvasive method for ischemic MMD control by relieving symptoms and reducing stroke recurrence. In addition, the effects of RIC on reducing neurological complications in MMD patients treated with revascularization surgery has also been reported. However, the mechanism of RIC in reducing peri-operative complications for MMD patients is still unknown. Thus, we conducted a randomized controlled study to explore the safety and efficacy of RIC in adult MMD patients undergoing revascularization therapy

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients aged from 18 to 65 years old;
2. Subjects all performed digital subtraction angiography (DSA) and diagnosed with MMD accroding to the criteria recommended by the Research Committee on MMD (Spontaneous Occlusion of the Circle of Wills) of the Ministry of Health and Welfare of Japan in 201211.
3. Modified Rankin Scale (mRS) score<4;
4. Informed consent obtained from the patient or legally authorized representative.

Exclusion criteria

1. Subjects suffered from acute ischemic or hemorrhagic stroke within 3 months;
2. Severe hepatic or renal dysfunction;
3. Severe cardiac disease;
4. Severe hemostatic disorder or severe coagulation dysfunction;
5. Serious, advanced, or terminal illnesses with anticipated life expectancy of less than one year;
6. Patients with moyamoya syndrome caused by autoimmune disease, Down syndrome, neurofibromatosis, leptospiral infection, or previous skull-base radiation therapy;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups

RIC group

Experimental group

Description:

Patients in RIC group and control group will achieve RIC intervention and sham RIC intervention three times daily from 5 days before operation and 7 days post operation

Treatment:

Device: Remote ischemic conditioning

Control group

Sham Comparator group

Description:

Patients in control group, bilateral upper arm cuffs were inflated to a pressure of 60 mm Hg for 5 minutes, followed by 5 minutes of relaxation of the cuffs

Treatment:

Device: Remote ischemic conditioning