Remote Ischemic Conditioning Device for Stroke
(TRIC-SVD Trial)

Recruiting in Palo Alto (17 mi)

Overseen byAravind Ganesh, MD, DPhil

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Calgary

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults over 18 with Cerebral Small Vessel Disease (CSVD). Participants must show specific brain changes on CT/MRI or have a history of small vessel ischemic stroke. It includes those with cognitive complaints or diagnosed acute ischemic strokes evaluated in a Mobile Stroke Unit.

Inclusion Criteria

I have been diagnosed with an acute ischemic stroke.

I was assessed in a Mobile Stroke Unit.

I am 18 years old or older.

+2 more

Participant Groups

The trial tests a Remote Ischemic Conditioning (RIC) device on CSVD patients and during pre-hospital stroke care. Patients use the RIC device daily, with half initially receiving sham treatment before switching to true RIC after 30 days. The study also assesses the device's usability by healthcare professionals.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Remote Ischemic Conditioning (RIC)Experimental Treatment1 Intervention

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.

Group II: Sham RICPlacebo Group1 Intervention

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.