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

Launched by UNIVERSITY OF CALGARY · Jul 21, 2023

Keywords

ClinConnect Summary

This is an early-phase study testing a new device called Remote Ischemic Conditioning (RIC). In simple terms, RIC uses a cuff on the arm to briefly cut off and then restore blood flow, with the goal of protecting the brain in people with cerebral small vessel disease (CSVD) and in people having an ischemic stroke treated outside the hospital. For CSVD, about 24 adults will use the device once daily for 60 days. Half will receive the real RIC and the other half a sham (fake) version for the first 30 days, after which the sham group crosses over to real RIC. A separate group of up to 10 adults with acute ischemic stroke will get real RIC during transport in a mobile stroke unit. The device can be remotely programmed, and the first 30 days are designed to keep participants and researchers unaware of who is getting real versus sham treatment.

Who may be eligible? Adults 18 and older with CSVD (shown on brain scans and with either cognitive concerns or a history of small-vessel stroke) or adults with an acute ischemic stroke treated in a mobile stroke unit. Key exclusions include serious trouble with speaking or understanding, inability to give consent, a high risk of bleeding or certain arm injuries that prevent using the cuff, and some blood thinner or vascular conditions. Participants will undergo daily 10-minute sessions (4 short cycles per session) for up to 60 days (CSVD) and will be monitored for safety, completion of sessions (a goal is to finish at least 80%), and any pain or discomfort. The study is based at Foothills Medical Centre in Calgary, led by the University of Calgary, and results aren’t available yet.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * For patients with Cerebral Small Vessel Disease (CSVD):
• • 1. Age ≥18 years
• • 2. 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
• • 3. 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:
• • 1. Age ≥18 years
• • 2. Evaluated in the Mobile Stroke Unit
• • 3. Diagnosed as having an acute ischemic stroke (all MSU code stroke activations during the study will be tracked)
• Exclusion Criteria:
• * For patients with CSVD:
• • 1. Unable to converse meaningfully (severe dementia or post-stroke deficit)
• • 2. No phone access for study monitoring and follow-up (either cell or landline)
• • 3. Therapeutic anticoagulation or other bleeding diathesis posing an unacceptable risk in physician's opinion (antiplatelet therapy is permitted)
• • 4. Any vascular, soft-tissue, or orthopedic injury that in the physician's opinion contraindicates arm ischemic preconditioning
• • 5. History of peripheral vascular disease, such as subclavian or other upper limb arterial stenosis or occlusion
• * For patients with ischemic stroke:
• • 1. Unable to give consent or assent by proxy (written or recorded by MSU audio-video)
• • 2. Therapeutic anticoagulation or other bleeding diathesis as with CSVD above
• • 3. Any vascular, soft-tissue, or orthopedic injury that in the physician's opinion contraindicates arm ischemic preconditioning
• • 4. History of peripheral vascular disease, such as subclavian or other upper limb arterial stenosis or occlusion