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ENROLLING BY INVITATION
NCT05967728
PHASE2

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

Sponsor: University of Calgary

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

55 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2024-12-01

Completion Date

2026-12-31

Last Updated

2024-12-31

Healthy Volunteers

No

Interventions

DEVICE

Remote ischemic conditioning (RIC) progammable device

RIC induces brief periods of ischemia-reperfusion in a limb. In our study, this is accomplished using a new device that can be remotely programmed to deliver either true RIC or a sham protocol, with remote monitoring capabilities to track completion of treatment sessions.

Locations (1)

Foothills Medical Centre

Calgary, Alberta, Canada