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

Launched by CAPITAL MEDICAL UNIVERSITY · Jun 3, 2018

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of a treatment called Remote Ischemic Conditioning (RIC) for children with Moyamoya Disease (MMD) who are undergoing revascularization surgery. Moyamoya Disease can lead to serious problems like strokes, and while surgery is a common treatment to prevent these issues, it can sometimes cause complications. RIC is a simple, non-invasive method that might help protect the brain and reduce the risk of these complications during and after surgery.

To be eligible for this trial, participants need to be between birth and 18 years old, have specific types of MMD diagnosed through imaging tests, and show signs of reduced blood flow to the brain, such as headaches or seizures. The trial is currently recruiting patients, and those who join will be closely monitored to see how well RIC works in preventing complications. It's important to know that certain medical conditions or previous treatments may exclude some patients from participating, but for those who qualify, this could be an opportunity to help improve outcomes in MMD treatment.

Gender

ALL

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
• • 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.