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

Study acronym: RIC-PMD
StatusUnknown
PhaseNot applicable
Started
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Record status
This record was last updated September 19, 2024 (before its estimated December 30, 2024 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v4
  3. Notable Enrollment target: 68 to 42v3 Show 7 more changesShow less
    • Primary completion date: Dec 30, 2020 to Dec 30, 2024
    • Start date: Dec 30, 2019 to Sep 10, 2024
    • Primary endpoint revised
    • Study completion date: Dec 30, 2020 to Feb 28, 2025
    • Interventions: RIC group (Device), sham group (Device) to Medication group (Other), RIC group (Device)
    • Secondary endpoints: 19 to 22
    • Collaborators expanded, about 3 words
  4. Notable Primary completion date: Jan 30, 2019 to Dec 30, 2020
    • Start date: Jun 30, 2018 to Dec 30, 2019
    • Study completion date: Apr 30, 2019 to Dec 30, 2020
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03546309
Lead Sponsor Capital Medical University
Collaborators: Beijing 302 Hospital
Conditions
(from sponsor)
Moyamoya Disease, Pediatric
Related terms Moyamoya Disease
Enrollment 42 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov