The Safety and Efficacy of RIC on Adult Moyamoya Disease
Keywords
Abstract
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.
Dates
| Last Verified: | 12/31/2019 |
| First Submitted: | 07/02/2019 |
| Estimated Enrollment Submitted: | 07/06/2019 |
| First Posted: | 07/08/2019 |
| Last Update Submitted: | 01/03/2020 |
| Last Update Posted: | 01/06/2020 |
| Actual Study Start Date: | 07/09/2019 |
| Estimated Primary Completion Date: | 12/14/2020 |
| Estimated Study Completion Date: | 12/29/2020 |
Condition or disease
Intervention/treatment
Device: RIC group
Device: sham-RIC group
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: RIC group 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. | Device: RIC group 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. |
| Sham Comparator: sham-RIC group Patients with AIS complicating ACS who were eligible for this study received standardized medical treatment and secondary prevention, including antiplatelets, low molecular weight heparin for anticoagulation，statins for lipid-lowering and stabilizing plaque, nitrates for vascular expansion and cardiocerebrovascular risk factors management. Administration of antihypertensive, antidiabetic or other agents were elective at the discretion of the treating physician according to the conditions of the patients. In addition, patients underwent sham-RIC twice daily for 14 days.And the sham-RIC procedure during which bilateral arm cuffs are inflated to a pressure of 60mmHg for five cycles of 5 min followed by 5 min of relaxation of the cuffs. | Device: sham-RIC group The sham-RIC procedure during which bilateral arm cuffs are inflated to a pressure of 60mmHg for five cycles of 5 min followed by 5 min of relaxation of the cuffs. |
Eligibility Criteria
| Ages Eligible for Study | 1 Year To 1 Year |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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. |
Outcome
Primary Outcome Measures
1. cerebral blood flow [change from the baseline to12 months after treatment]
2. perfusion status [change from the baseline to 12 months after treatment]
Secondary Outcome Measures
1. incidence of ischemic stroke [from the baseline to 12 months after treatment]
2. incidence of transient ischemic attack [from the baseline to 12 months after treatment]
3. incidence of hemorrhagic stroke [from the baseline to 12 months after treatment]
4. wall area [change from the baseline to 6, 12 months after treatment]
5. remodeling index [change from the baseline to 6, 12 months after treatment]
6. the degree of enhancement of vessel wall [change from the baseline to 6, 12 months after treatment]
7. The level of matrix metalloproteinase 9 (MMP-9) [change from the baseline to 3, 6, 12 months after treatment]
8. The level of vascular endothelial growth factor [change from the baseline to 3, 6, 12 months after treatment]
9. The level of basic fibroblast growth factor [change from the baseline to 3, 6 ,12 months after treatment]
10. The rate of death and adverse event [change from the baseline to 12 months after treatment]
11. The number of patients with erythema,and/or skin lesions related to RIC [change from the baseline to 12 months after treatment]
12. The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure [change from the baseline to 12 months after treatment]
13. the total length of lenticulostriate arteries [change from the baseline to 6, 12 months after treatment]
14. average length of lenticulostriate arteries [change from the baseline to 6, 12 months after treatment]
15. the number of lenticulostriate arteries [change from the baseline to 6, 12 months after treatment]
