Testing of a System for Remote Ischemic Conditioning in Cerebral Small Vessel Disease and Pre-hospital Stroke Care
Cerebral Small Vessel Diseases, Cerebral Small Vessel Ischemic Disease, Ischemic Stroke
About this trial
This is an interventional treatment trial for Cerebral Small Vessel Diseases focused on measuring Remote ischemic conditioning
Eligibility Criteria
Inclusion Criteria: For patients with Cerebral Small Vessel Disease (CSVD): 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 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: Must be evaluated in the Mobile Stroke Unit (MSU) Diagnosed as having an acute ischemic stroke (all MSU code stroke activations during the study will be tracked) Exclusion Criteria: 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) 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Remote Ischemic Conditioning (RIC)
Sham RIC
For the CSVD patients, each RIC session consists of 4 cycles of inflating a blood-pressure cuff around an upper arm to reduce blood flow to that limb for approximately 5 minutes, after which it is deflated for around 5 minutes to restore normal blood flow. The procedure will use the RIC auto-control device with a cuff that inflates to a pressure of up to 200 mmHg. The patients will use the device once daily for a total of 60 days. For the MSU patients in the non-randomized component of the study, the device cuff will inflate around a limb to reduce blood flow for approximately 5 minutes, after which it will deflate for around 5 minutes to restore normal blood flow. This cycle will repeat (for a maximum of 6 cycles) until the patient is transferred to the hospital for further management.
For the CSVD patients randomized to sham, each RIC session consists of 4 cycles of inflating a blood-pressure cuff around an upper arm to 30mmHg for approximately 5 minutes, after which it is deflated for around 5 minutes. The procedure will use the same RIC device as the treatment arm, just randomized to run the sham protocol. The patients will use the device once daily for a total of 30 days. After 30 days, they will cross over to true RIC as described above, once daily for the remaining 30 days, accomplished by remote reprogramming of their device protocols.