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

Last updated: September 12, 2024
Sponsor: Capital Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Moyamoya Syndrome

Treatment

RIC group

Medication group

Clinical Study ID

NCT03546309
RIC-PMD
  • Ages < 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Age: ≥0 and ≤18

  • All of the patients underwent digital subtraction angiography and met the currentdiagnostic criteria recommended by the Research Committee on MMD (SpontaneousOcclusion 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

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 causedby autoimmune disease, Down syndrome, neurofibromatosis, leptospiral infection, orprevious 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 orvalvular vegetation, congestive heart failure, bacterial endocarditis, or any othercardiovascular condition interfering with participation

  • Serious, advanced, or terminal illnesses with anticipated life expectancy of lessthan one year

  • Patient participating in a study involving other drug or device trial study

  • Patients with existing neurological or psychiatric disease that would confound theneurological or functional evaluations

  • Unlikely to be available for follow-up for 3 months

  • Contraindication for RIC - severe soft-tissue injury, fracture, or peripheralvascular disease in the upper limbs.

Study Design

Total Participants: 42
Treatment Group(s): 2
Primary Treatment: RIC group
Phase:
Study Start date:
September 10, 2024
Estimated Completion Date:
February 28, 2025

Study Description

This study will provide insights into the preliminary proof of principle, safety, and efficacy of RIC in pediatric MMD patients undergoing revascularization surgery therapy, and this data will provide parameters for future larger scale clinical trials if efficacious.

Connect with a study center

  • The Fifth Medical Center of Chinese PLA General Hospital

    Beijing, Beijing
    China

    Active - Recruiting

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