Testing of a System for Remote Ischemic Conditioning in Cerebral Small Vessel Disease and Pre-hospital Stroke Care
Key facts
- Where
- Calgary, CanadaSee the site
- Phase
- Phase 2
Where in Canada
- Foothills Medical CentreCalgary, CanadaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Calgary
- Trial code
- NCT05967728
- Record updated
- 31 December 2024
- Original description
This early phase trial will address the following key objectives:Read full original descriptionShow less
Testing of a System for Remote Ischemic Conditioning in Preparation for Clinical Trials in Cerebral Small Vessel Disease and Pre-hospital Stroke Care
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.
Inclusion: For patients with Cerebral Small Vessel Disease (CSVD):; Age ≥18 years; Evidence of CSVD, defined as (a) beginning confluent white-matter changes (Age-Related White Matter Changes grade 2) on any slice on CT/MRI Brain(21) OR (b) ≥2 supratentorial subcortical infarcts; Either (a) cognitive complaints from the patient or family member OR (b) history of small vessel ischemic stroke with corresponding evidence of brain infarct on CT or MRI that is attributed by the treating physician to CSVD; For patients with ischemic stroke:; Age ≥18 years; Evaluated in the Mobile Stroke Unit; Diagnosed as having an acute ischemic stroke (all MSU code stroke activations during the study will be tracked).
Exclusion: For patients with CSVD:; Unable to converse meaningfully (severe dementia or post-stroke deficit); No phone access for study monitoring and follow-up (either cell or landline); Therapeutic anticoagulation or other bleeding diathesis posing an unacceptable risk in physician's opinion (antiplatelet therapy is permitted); Any vascular, soft-tissue, or orthopedic injury that in the physician's opinion contraindicates arm ischemic preconditioning; History of peripheral vascular disease, such as subclavian or other upper limb arterial stenosis or occlusion; For patients with ischemic stroke:; Unable to give consent or assent by proxy (written or recorded by MSU audio-video); Therapeutic anticoagulation or other bleeding diathesis as with CSVD above; Any vascular, soft-tissue, or orthopedic injury that in the physician's opinion contraindicates arm ischemic preconditioning; History of peripheral vascular disease, such as subclavian or other upper limb arterial stenosis or occlusion.