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

NCT ID: NCT03821181

Last Updated: 2019-11-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-08
• Study Completion Date: 2020-08-31

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

Conditions

Moyamoya Disease; TIA; Children; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

RIC group

Intervention Type: DEVICE

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 group

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.

Group Type: SHAM_COMPARATOR

Sham group

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Sham group

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

307 Hospital of PLA

OTHER

Sponsor Role: collaborator

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ji Xunming,MD,PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Xunming Ji, MD PhD

Role: CONTACT

Jixunming@vip.163.com;

108613911077166

Sijie Li, MD

Role: CONTACT

phoenix0537@sina.com

1083199439

Other Identifiers

RIC-PMD-1

Identifier Type: -

Identifier Source: org_study_id