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Safety and Efficacy of RIC in Pediatric Moyamoya Disease Patients Treated With Revascularization Therapy

ConditionsMoyamoya DiseasePediatric
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorCapital Medical University

About this trial

Revascularization surgery has been the standard treatment to prevent ischemic stroke in pediatric Moyamoya disease (MMD) patients with ischemic symptoms. However, perioperative complications, such as hyperperfusion syndrome, new infarct on imaging, or ischemic stroke, are inevitable. Remote ischemic conditioning (RIC) is a noninvasive and easy-to-use neuroprotective strategy, and it has potential effects on preventing hyperperfusion syndrome and ischemic infarction.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Suzuki stages concentrated in Stage III and IV

Presentation with ischemic symptoms, such as transient ischemic attack (TIA), headache, seizure, hemorrhagic stroke, and ischemic stroke confirmed by MRI

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Medication group

    Other intervention

    Patients allocated to Medication group will accept medication treatment by professional neurologists

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: RIC groupExperimental treatment 1 intervention
Group B: Medication groupOther 1 intervention

Trial outcomes

Primary outcomes

1

the incidence of major neurologic complications

Including transient ischemic attack, cerebral infarction, intracranial hemorrhage, and seizures.

Time frame
during the perioperative period

Secondary outcomes

1

The score of National Institute of Health stroke scale score

National Institute of Health Stroke Scale (NIHSS) is considered as a standardized assessment of neurological functions in the acute phase of stroke, and it is generally used to quantify patient's neurological impairments on 15 items in 11 fields of different neurological status.The score of the scale ranges from 0 to 42.And higher score indicates worse neurological function.

Time frame
change from baseline (preoperation) at 24 hours, 48 hours, 72 hours, and at 5-7 days or if discharged earlier
2

The score of Modified Rankin scale score

The Modified Rankin Scale Score (mRS) is the most comprehensive and most widely used primary outcome measurement to assess the neurological functional disability in contemporary acute stroke trials. The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranges from 0 (no symptom) to 5 (severe disability) and 6 (death). We will use mRS to evaluate the degree of disability or dependence during daily activities. The mRS will be assessed by certified study investigator, who is blinded to the treatment assignment, at 90 days postoperation. The distribution of mRS will be compared between groups

Time frame
change from baseline (pre-RIC treatment) at 180 days after revascularization therapy
3

Symptomatic intracerebral hemorrhage

Symptomatic intracranial hemorrhage, including any subarachnoid hemorrhage associated with clinical symptoms and symptomatic intracerebral hemorrhage. Head computed tomography or 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.

Time frame
during the first 180 days after revascularization therapy
4

Incidence of new infarct in brain

Head MRI is a precise method which is commonly used to evaluate weather there's new infarct in brain.

Time frame
during 72 hours and 180 days after revascularization therapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Capital Medical University

Lead sponsor

Beijing 302 Hospital

Collaborator

Source ClinicalTrials.gov
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