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

NCT03821181 | Unknown

• 1 other identifier: RIC-PMD-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Moyamoya Disease; TIA; Children; Stroke

Keywords

pediatric moyamoya disease; TIA; Stroke; Remote ischemic conditioning

Outcome Measures

Primary Outcomes (2)

• The incidence rate of transient ischemic attack(TIA)

  TIA means transient ischemic attack, two neurologists will evaluate patients with ischemic symptoms and make diagnosis.magnetic reasoning imaging (MRI) scan will be performed to confirm intracerebral hemorrhage, and the imaging will be evaluated by two independent neuroradiologists who are blinded to the study assignment.

  during baseline to 12months after therapy

• The incidence rate of ischemic stroke

  Two neurologists will evaluate patients with ischemic symptoms and make diagnosis.magnetic reasoning imaging (MRI) scan will be performed to confirm intracerebral hemorrhage, and the imaging will be evaluated by two independent neuroradiologists who are blinded to the study assignment.

  during baseline to 12months after therapy

Secondary Outcomes (24)

• 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

Study Arms (2)

RIC group

EXPERIMENTAL

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

sham group

SHAM COMPARATOR

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.

Device: Sham group

Interventions

RIC group 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.

RIC group

Sham group 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.

sham group

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead
• 307 Hospital of PLA: collaborator

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Moyamoya Disease; Stroke

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Xunming Ji, MD PhD

CONTACT

108613911077166; Jixunming@vip.163.com;

Sijie Li, MD

CONTACT

1083199439; phoenix0537@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 29, 2019
• Study Start: December 8, 2019
• Primary Completion: July 1, 2020
• Study Completion: August 1, 2020
• Last Updated: November 20, 2019

Record last verified: 2019-11

Locations

CN (1)