The Effect of RIC on TIA/Stroke in Children With Moyamoya Disease

Remote Ischemic Conditioning Prevents Ischemic Cerebrovascular Events In Children With Moyamoya Disease: A Randomized Controlled Trial

Sponsors

Lead Sponsor: Capital Medical University

Collaborator: 307 Hospital of PLA

Source Capital Medical University
Brief Summary

Moyamoya disease is a common reason of transient ischemic attack (TIA) and stroke in children. Remote ischemic conditioning (RIC) has been shown to prevent recurrent stroke in intracranial arterial stenosis, but it is unclear whether RIC can prevent TIA or stroke in children with moyamoya disease. This study aims to evaluate the effect of RIC on TIA/stroke in children with moyamoya disease.

Detailed Description

This study will provide insights into the preliminary proof of principle, safety, and efficacy of RIC in pediatric MMD patients, and this data will provide parameters for future larger scale clinical trials if efficacious

Overall Status Not yet recruiting
Start Date 2019-12-08
Completion Date 2020-08-01
Primary Completion Date 2020-07-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
The incidence rate of transient ischemic attack(TIA) during baseline to 12months after therapy
The incidence rate of ischemic stroke during baseline to 12months after therapy
Secondary Outcome
Measure Time Frame
Cerebral perfusion change from baseline to 12months after therapy
The mean blood flow velocity of cerebral vascular detected by TCCD changes form baseline to 6months,12months after therapy
The score of National Institute of Health stroke scale score during baseline to 12months after therapy
The score of Modified Rankin scale score during baseline to 12months after therapy
Incidence rate of symptomatic intracerebral hemorrhage during baseline to 12months after therapy
The number of cerebral lacunar infarction changes from baseline to 12months after therapy
The volume of cerebral lacunar infarction changes from baseline to 12 months after therapy
The rate of death and adverse event during baseline to 12months after therapy
Number of distal radial pulses changes from baseline to 6, 12months after therapy
Visual inspection of local edema of fundus oculi changes from baseline to 6, 12months after therapy
The number of patients with erythema,and/or skin lesions related to RIC changes from baseline to 6, 12months after therapy
Palpation for tenderness changes from baseline to 6, 12months after therapy
The number of patients not tolerating RIC procedure,and refuse to continue the RIC procedure during baseline to 12months after therapy
The number of patients with any other adverse events related to RIC intervention during baseline to 12months after therapy
The score of ABCD2 during baseline to 12months after therapy
The level of S-100A4 change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy
The level of matrix metalloproteinase 9 (MMP-9) change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy
The level of basic fibroblast growth factor change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy
The level of platelet derived growth factor change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy
The level of vascular endothelial growth factor change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy
The level of hs-CRP(high-sensitive C-reactive protein) change from baseline (pre-RIC treatment) to 6 months ,12 months after therapy
cerebral perfusion examined by SPECT from baseline(pre-RIC treatment) to 12 months after therapy
cerebral perfusion examined by ASL from baseline(pre-RIC treatment) to 12 months after therapy
variant of the RNF-213 gene from baseline(pre-RIC treatment) to 12 months after therapy
Enrollment 50
Condition
Intervention

Intervention Type: Device

Intervention Name: RIC 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.

Arm Group Label: RIC group

Intervention Type: Device

Intervention Name: Sham group

Description: patients allocated to the sham group will undergo a sham RIC procedure during which bilateral arm cuffs are inflated to a pressure of 30 mmHg for five cycles of 5 min, followed by 5 min of relaxation of the cuffs.

Arm Group Label: sham group

Eligibility

Criteria:

Inclusion Criteria: - Age: ≥0 and ≤18 - all of the patients underwent digital subtraction angiography and met the current diagnostic criteria recommended by the Research Committee on MMD (Spontaneous Occlusion of the Circle of Willis) of the Ministry of Health and Welfare of Japan in 2012 - The CVR of patients detected by SPECT is not impaired severely - The patients didn't suffer stroke before. - Informed consent obtained from patient or acceptable patient's surrogate Exclusion Criteria: - Severe hepatic or renal dysfunction - Severe hemostatic disorder or severe coagulation dysfunction - Patients with unilateral MMD or the presence of secondary moyamoya phenomenon caused by autoimmune disease, Down syndrome, neurofibromatosis, leptospiral infection, or previous skull-base radiation therapy - Any of the following cardiac disease - rheumatic mitral and or aortic stenosis, prosthetic heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, patent foramen ovale, left ventricular mural thrombus or valvular vegetation, congestive heart failure, bacterial endocarditis, or any other cardiovascular condition interfering with participation - Serious, advanced, or terminal illnesses with anticipated life expectancy of less than one year - Patient participating in a study involving other drug or device trial study - Patients with existing neurological or psychiatric disease that would confound the neurological or functional evaluations - Unlikely to be available for follow-up for 3 months - Contraindication for RIC - severe soft-tissue injury, fracture, or peripheral vascular disease in the upper limbs.

Gender:

All

Minimum Age:

1 Month

Maximum Age:

18 Years

Healthy Volunteers:

No

Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility: Xuanwu Hospital, Capital Medical University
Location Countries

China

Verification Date

2019-11-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Capital Medical University

Investigator Full Name: Ji Xunming,MD,PhD

Investigator Title: Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: RIC group

Type: Experimental

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.

Label: sham group

Type: Sham Comparator

Description: patients allocated to the sham group will undergo a sham RIC procedure during which bilateral arm cuffs are inflated to a pressure of 30 mmHg for five cycles of 5 min, followed by 5 min of relaxation of the cuffs.

Acronym RIC-PMD-1
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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