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Studies

Interventional Not yet recruiting Phase 2

NCT05967728 on ClinicalTrials.gov

Testing of a System for Remote Ischemic Conditioning in Cerebral Small Vessel Disease and Pre-hospital Stroke Care

Official title: Testing of a System for Remote Ischemic Conditioning in Preparation for Clinical Trials in Cerebral Small Vessel Disease and Pre-hospital Stroke Care

  • Sponsor: University of Calgary
  • Enrollment: 24 (Estimated)
  • Study start: 2024-09-01 (Estimated)
  • Primary completion: 2025-09-15 (Estimated)
  • Study completion: 2026-12-15 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Crossover
  • InterventionModelDescription: The randomized-controlled trial component of the study will involve 24 patients with CSVD, randomized 1:1 to either receive RIC for the full 60-days, or sham treatment (inflation to 30mmHg) for the first 30-days followed by cross-over to RIC. The MSU-based component of the study, consisting of 10 patients with acute ischemic stroke, will not involve randomization and all participants will be receiving true RIC.
  • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief Summary

This early phase trial will address the following key objectives:

1. Completion of initial safety and tolerability testing of our viable prototype for remote ischemic conditioning (RIC) with patients with (a) CSVD and (b) acute ischemic stroke.
2. Usability testing of the prototype with patients and healthcare professionals, with further optimization.

Approximately 24 patients with CSVD will be recruited to use the RIC device daily for 60 days and provide feedback. They will be randomized in a 1:1 ratio to either true RIC therapy or sham control for the first 30 days, after which the sham group will cross over to receive true RIC for the remaining 30 days.

Feasibility testing will be done in the mobile stroke unit on up to 10 patients with acute ischemic stroke.

An additional 10 stroke physicians and paramedics will conduct device usability testing and provide feedback.

Conditions

  • Cerebral Small Vessel Diseases
  • Cerebral Small Vessel Ischemic Disease
  • Ischemic Stroke
  • Vascular Cognitive Impairment
  • Stroke, Acute

Intervention / Treatment

  • Device: Remote ischemic conditioning (RIC) progammable device

Primary Outcome Measures

  • Treatment adherence or completion (60 days of daily sessions for patients with CSVD, 6 cycles (each cycle length: 10 minutes) for MSU-based patients with stroke)
    Proportion of total planned sessions completed. Successful adherence will be defined as completing ≥80% of sessions.

Study Officials