The Neuroprotective Effect of Remote Ischemic Conditioning in Aneurysm Coiling Therapy

Overview

The overall incidence of DWI positive for thromboembolic events following endovascular treatment of intracranial aneurysms is proximately 50%. Whether remote ischemic conditioning was safe and effective to reduce ischemic brain lesions on DWI after endovascular treatment of intracranial aneurysms is still unclear. The investigators' hypothesis is that remote ischemic conditioning is a safe and effective strategy to reduce new ischemic lesions in intracranial aneurysms patients undergoing endovascular treatment.

Full Title of Study: “The Neuroprotective Effect of Remote Ischemic Conditioning in Aneurysm Coiling”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 1, 2018

Interventions

  • Device: remote ischemic conditioning
    • Remote ischemic conditioning is performed by using an electric autocontrol device with cuffs that inflated to a pressure of 200 mm Hg during the ischemic period (Patent No. CN200820123637.X, China)
  • Device: sham remote ischemic conditioning
    • sham remote ischemic conditioning is performed by using an electric autocontrol device with cuffs that inflated to a pressure of 60 mm Hg

Arms, Groups and Cohorts

  • Experimental: Remote ischemic conditioning
  • Sham Comparator: Sham remote ischemic conditioning

Clinical Trial Outcome Measures

Primary Measures

  • The presence of ≥1 new brain lesions on DWI
    • Time Frame: within 72 hours after endovascular treatment
    • Assessed by DWI

Secondary Measures

  • Number of new ischemic lesions
    • Time Frame: within 72 hours after endovascular treatment
  • Volume of new ischemic lesions
    • Time Frame: within 72 hours after endovascular treatment
  • National Institutes of Health Stroke Scale
    • Time Frame: 7 days or discharge
    • Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits.
  • Cerebrovascular events
    • Time Frame: 30 days
    • Cerebrovascular events included ischemic stroke, hemorrhagic stroke, and TIA.
  • Nondisabling events
    • Time Frame: 30 days
    • Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits.National Institutes of Health Stroke Scale ≤3 or TIA is defined as nondisabling events
  • Modified Rankin Scale
    • Time Frame: 30 days
    • Scores on the modified Rankin scale of functional disability range from 0 (no symptoms) to 6 (death).

Participating in This Clinical Trial

Inclusion Criteria

  • Age 18 years or older – Unruptured brain aneurysm deemed suitable for neuroendovascular repair – Normal baseline brain MRI – Female subjects of childbearing potential have a negative pregnancy test. – Signed informed consent prior to entering study Exclusion Criteria:
  • Dissecting or mycotic brain aneurysm. – Planned endovascular vessel sacrifice as the primary modality for aneurysm treatment – Severe, sustained hypertension (SBP > 185 mmHg or DBP > 110 mmHg) – Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs – Pre-morbid modified Rankin scale score of greater than 1 – Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations – Patients who are unable to have an MRI scan for any reason. – Currently participating or previously participated in any investigational drug or device study within 6 months
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Capital Medical University
    • Provider of Information About this Clinical Study
      • Principal Investigator: Ji Xunming,MD,PhD, MD – Capital Medical University
    • Overall Contact(s)
      • Xunming Ji, MD, 008601083198930, jixm@ccmu.edu.cn

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