Status:
ENROLLING_BY_INVITATION
Testing of a System for Remote Ischemic Conditioning in Cerebral Small Vessel Disease and Pre-hospital Stroke Care
Lead Sponsor:
University of Calgary
Conditions:
Cerebral Small Vessel Diseases
Cerebral Small Vessel Ischemic Disease
Eligibility:
All Genders
55+ years
Phase:
PHASE2
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...
Detailed Description
Cerebral Small Vessel Disease (CSVD) causes 20-25% of strokes and is the most common cause of Vascular Cognitive Impairment (VCI). Patients with CSVD accumulate frequent, small brain infarcts, leading...
Eligibility Criteria
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
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05967728
Start Date
December 1 2024
End Date
December 31 2026
Last Update
December 31 2024
Active Locations (1)
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1
Foothills Medical Centre
Calgary, Alberta, Canada, T3R1B9