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Clinical Trials in China / NCT03546309
Recruiting Not applicable

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

NCT03546309 · tracked via the Priya Life Science China tracker
Sponsor
Capital Medical University
Phase
Not applicable
Started
2024-09-10
Last updated
2024-09-19

Condition(s) studied

Moyamoya DiseasePediatric

Investigational drug(s) / intervention(s)

RIC groupMedication group

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.

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

Study summary

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

Sex
ALL
Min age
Max age
18 Years
Healthy volunteers
No
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 * 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 * 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The Fifth Medical Center of Chinese PLA General Hospital Beijing Beijing Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03546309 on ClinicalTrials.gov ↗ ← All trials in China