Ischemic Stroke Clinical Trial
— TRIC-SVDOfficial title:
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.
Status | Not yet recruiting |
Enrollment | 24 |
Est. completion date | December 15, 2026 |
Est. primary completion date | September 15, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years and older |
Eligibility | Inclusion Criteria: - For patients with Cerebral Small Vessel Disease (CSVD): 1. 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 OR (b) =2 supratentorial subcortical infarcts 2. 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. Must be evaluated in the Mobile Stroke Unit (MSU) 2. 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) - 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Calgary |
Ganesh A, Smith EE, Hill MD. Remote ischaemic conditioning for stroke prevention. Lancet Neurol. 2022 Dec;21(12):1062-1063. doi: 10.1016/S1474-4422(22)00438-0. Epub 2022 Oct 27. No abstract available. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment adherence or completion | Proportion of total planned sessions completed. Successful adherence will be defined as completing =80% of sessions. | 60 days of daily sessions for patients with CSVD, 6 cycles (each cycle length: 10 minutes) for MSU-based patients with stroke | |
Secondary | Discontinuation | Cessation of device use | 60 days for patients with CSVD | |
Secondary | Pain or discomfort | Treatment-associated pain/discomfort levels reported using the Numeric Rating Scale for pain (based on subjective report, ranging from 0 [no pain] to 10 [worst possible pain]) | 30 days and 60 days for patients with CSVD |
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