Remote Ischemic Conditioning Device for Stroke

(TRIC-SVD Trial)

Overseen By Cody Doolan, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Calgary

Must not be taking: Therapeutic anticoagulation

Disqualifiers: Severe dementia, No phone access, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 60 days

24 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on therapeutic anticoagulation (blood thinners), you may not be eligible to participate.

What data supports the effectiveness of the treatment Remote Ischemic Conditioning (RIC) for stroke?

Research shows that Remote Ischemic Conditioning (RIC) can help improve recovery after a stroke by protecting the brain and increasing blood flow. Studies suggest it may also prevent future strokes and improve outcomes when combined with other treatments. ^{1 2 3 4 5}

Is the Remote Ischemic Conditioning Device safe for humans?

Remote Ischemic Conditioning (RIC) has been shown to be safe and feasible for patients with acute ischemic stroke, including those undergoing treatments like intravenous thrombolysis and endovascular treatment. ^{2 3 4 6 7}

How is the Remote Ischemic Conditioning treatment for stroke different from other treatments?

Remote Ischemic Conditioning (RIC) is unique because it is a noninvasive procedure that uses brief periods of reduced blood flow to one part of the body to protect the brain from damage during a stroke. Unlike other treatments, RIC can be used both to improve recovery after a stroke and potentially prevent future strokes, making it a versatile and promising option. ^{1 2 3 5 8}

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.

Research Team

Aravind Ganesh, MD, DPhil

Principal Investigator

University of Calgary

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 have signs of small vessel disease in my brain, as shown by MRI or CT scans.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants with CSVD use the RIC device daily for 60 days, with a crossover from sham to true RIC after 30 days

60 days

Initial visit for device demonstration, daily self-administered sessions

Usability Testing

Usability testing of the RIC device by stroke physicians and paramedics, including mock acute stroke scenarios

1 session

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Remote Ischemic Conditioning (RIC) progammable device

Trial Overview 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.

Participant Groups

Group I: Remote Ischemic Conditioning (RIC) Experimental Treatment 1 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 RIC Placebo Group 1 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.

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Findings from Research

The SERIC-IVT trial is evaluating the effectiveness and safety of remote ischemic conditioning (RIC) combined with intravenous thrombolysis (IVT) in 558 patients with acute ischemic stroke, aiming to improve functional outcomes at 90 days.

The study will assess whether RIC can lead to a 13.14% increase in favorable outcomes, measured by the modified Rankin Scale, while also monitoring for safety issues such as mortality and adverse events within the same period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of remote ischemic conditioning combined with intravenous thrombolysis for acute ischemic stroke: A multicenter, randomized, parallel-controlled clinical trial (SERIC-IVT) Study design and protocol. Abuduxukuer, R., Guo, ZN., Zhang, P., et al.[2023]

Remote ischemic conditioning (RIC) has been shown to significantly reduce the recurrence of ischemic stroke and improve patient prognosis at 90 days, based on a meta-analysis of 6392 patients from 17 randomized controlled trials.

RIC is considered safe, as it does not increase the risk of serious adverse events like death or intracerebral hemorrhage, although it may cause some benign RIC-related adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of remote ischemic conditioning for acute ischemic stroke: A comprehensive meta-analysis from randomized controlled trials. Kan, X., Yan, Z., Wang, F., et al.[2023]

Remote ischemic conditioning (RIC) combined with intravenous thrombolysis (IVT) is safe for treating acute ischemic stroke, showing no significant differences in hemorrhagic transformation or adverse events compared to a sham treatment in a study of 49 patients.

While RIC did not improve overall functional outcomes measured by the modified Rankin Scale or NIHSS scores, it significantly reduced levels of high-sensitivity C-reactive protein, suggesting potential anti-inflammatory benefits that merit further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote ischemic conditioning combined with intravenous thrombolysis for acute ischemic stroke. He, YD., Guo, ZN., Qin, C., et al.[2021]

Remote ischemic conditioning (RIC) was found to be safe and feasible for 20 patients with acute ischemic stroke undergoing endovascular treatment, with no serious RIC-related adverse events reported during the study.

At the 3-month follow-up, 55% of patients achieved functional independence, suggesting potential benefits of RIC, although further research is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote ischemic conditioning for acute stroke patients treated with thrombectomy. Zhao, W., Che, R., Li, S., et al.[2022]

A single application of remote ischemic conditioning (RIC) in 47 patients with chronic cerebral vascular stenosis showed significant changes in inflammatory and coagulation markers, particularly in those with cerebral arteriostenosis, indicating its potential neuroprotective effects.

In patients with cerebral arteriostenosis, RIC led to a decrease in fibrinogen levels and an increase in interleukin-6, suggesting a complex interplay of pro-inflammatory and anti-coagulation effects, while older age negatively impacted several biomarkers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential Anti-Inflammatory and Anti-Coagulation Effects of One-Time Application of Remote Ischemic Conditioning in Patients With Subacute/Chronic Cerebral Arteriostenosis and Venostenosis. Song, SY., Jiao, BL., Lan, D., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of remote ischemic conditioning combined with intravenous thrombolysis for acute ischemic stroke: A multicenter, randomized, parallel-controlled clinical trial (SERIC-IVT) Study design and protocol. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of remote ischemic conditioning for acute ischemic stroke: A comprehensive meta-analysis from randomized controlled trials. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Remote ischemic conditioning combined with intravenous thrombolysis for acute ischemic stroke. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Remote ischemic conditioning after stroke: Research progress in clinical study. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Remote ischemic conditioning for stroke: A critical systematic review. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Remote ischemic conditioning for acute stroke patients treated with thrombectomy. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Potential Anti-Inflammatory and Anti-Coagulation Effects of One-Time Application of Remote Ischemic Conditioning in Patients With Subacute/Chronic Cerebral Arteriostenosis and Venostenosis. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Phase I clinical trial for the feasibility and safety of remote ischemic conditioning for aneurysmal subarachnoid hemorrhage. [2022]