Remote Ischemic Conditioning in Adult Moyamoya Disease Patients

Not Applicable

Not yet recruiting

• Conditions: Remote Ischemic Conditioning; Moyamoya Disease
• Interventions: Device: Remote ischemic conditioning

• Registration Number: NCT05860946
• Lead Sponsor: Huashan Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-06
• Study First Submitted QC: 2023-05-06
• Last Update Submitted: 2023-05-06
• Study First Posted: 2023-05-16
• Last Update Posted: 2023-05-16
• Study Start: 2023-08-01
• Primary Completion: 2024-08-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 44

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RIC group	Remote ischemic conditioning	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
Control group	Remote ischemic conditioning	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

Primary Outcome Measures

Name	Time	Method
the incidence of major neurologic complications during perioperative period	2 weeks after operation

Secondary Outcome Measures

Name	Time	Method
The Modified Rankin Scale (MRS) score	at 90 days postoperation and at 1 year after operation