Actively Recruiting
Safety and Efficacy of RIC in Pediatric Moyamoya Disease Patients Treated With Revascularization Therapy
Led by Capital Medical University · Updated on 2024-09-19
42
Participants Needed
1
Research Sites
24 weeks
Total Duration
On this page
Sponsors
C
Capital Medical University
Lead Sponsor
B
Beijing 302 Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of RIC in Pediatric Moyamoya Disease Patients Treated With Revascularization Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 0 to 18 years
- Diagnosis of Moyamoya disease confirmed by digital subtraction angiography meeting 2012 Japanese Research Committee criteria
- Suzuki stages focused on Stage III and IV
- Presentation with ischemic symptoms such as transient ischemic attack, headache, seizure, hemorrhagic stroke, or ischemic stroke confirmed by MRI
- Informed consent obtained from patient or acceptable surrogate
You will not qualify if you...
- Severe liver or kidney dysfunction
- Severe bleeding or coagulation disorders
- Unilateral Moyamoya disease or secondary moyamoya due to autoimmune disease, Down syndrome, neurofibromatosis, leptospiral infection, or prior skull-base radiation
- Certain heart diseases including rheumatic valve stenosis, prosthetic heart valves, atrial fibrillation/flutter, sick sinus syndrome, atrial myxoma, patent foramen ovale, ventricular thrombus, valvular vegetation, congestive heart failure, bacterial endocarditis, or other cardiovascular conditions affecting participation
- Serious advanced or terminal illness with life expectancy less than one year
- Participation in another drug or device trial
- Existing neurological or psychiatric conditions that interfere with evaluations
- Unlikely to complete 3 months of follow-up
- Contraindications for RIC such as severe upper limb soft-tissue injury, fracture, or peripheral vascular disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Fifth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
X
Xunming Ji, MD PhD
CONTACT
S
Sijie Li, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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