Using remote ischemic conditioning to improve outcomes in children with Moyamoya disease undergoing surgery
Safety and Efficacy of Remote Ischemic Conditioning in Pediatric Moyamoya Disease Patients Treated With Revascularization Therapy
This study is testing if a special treatment called remote ischemic conditioning can help children with Moyamoya disease have safer surgery and avoid complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Capital Medical University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT03546309 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and efficacy of remote ischemic conditioning (RIC) in pediatric patients with Moyamoya disease who are undergoing revascularization surgery. The goal is to determine if RIC can prevent complications such as hyperperfusion syndrome and ischemic infarction during the perioperative period. By comparing outcomes between a group receiving RIC and a medication group, the study aims to provide preliminary evidence that could support larger future trials if RIC proves effective.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 0 to 18 diagnosed with Moyamoya disease and presenting with ischemic symptoms.
Not a fit: Patients with severe hepatic or renal dysfunction, severe coagulation disorders, or those with unilateral Moyamoya disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of complications during surgery for children with Moyamoya disease.
How similar studies have performed: While the use of remote ischemic conditioning is a relatively novel approach in this context, similar studies have shown promise in other patient populations.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- The Fifth Medical Center of Chinese PLA General Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Xunming Ji, MD PhD
- Email: 807595234@qq.com;
- Phone: +8613911077166
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.