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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment approach called Remote Ischemic Conditioning (RIC) for patients with certain types of strokes, including Cerebral Small Vessel Disease (CSVD) and acute ischemic stroke. The researchers aim to test the safety and usability of a programmable device that temporarily restricts blood flow in the arm to determine if it can protect the brain. Participants with CSVD will use the device at home for 60 days, while those with acute ischemic stroke will be tested in a mobile stroke unit. Ideal candidates are individuals who have experienced cognitive issues due to CSVD or have had a small vessel ischemic stroke with visible signs on a brain scan. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to important advancements in stroke care.

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 prior data suggests that this remote ischemic conditioning device is safe for stroke patients?

Studies have shown that remote ischemic conditioning (RIC) is generally safe for individuals who have experienced an ischemic stroke. RIC involves using a blood-pressure cuff to temporarily reduce blood flow. Research indicates that both short-term and long-term RIC sessions are well-tolerated, whether administered by healthcare professionals or caregivers. These studies have not reported any major safety concerns.

In some studies, patients did not experience serious side effects, and the process proved easy to use. This allows for its application at home or in a medical setting without major issues. Overall, the available research suggests that RIC is a safe option for patients with stroke-related conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Unlike traditional stroke treatments that typically involve medications or surgical interventions, Remote Ischemic Conditioning (RIC) uses a programmable device to improve blood flow. This novel approach involves inflating a blood-pressure cuff on the arm to temporarily reduce and then restore blood flow, which may help protect the brain from stroke damage. Researchers are excited about this method because it offers a non-invasive, potentially easily accessible way to aid recovery and could be a game-changer in early stroke management.

What evidence suggests that this remote ischemic conditioning device is effective for stroke?

This trial will evaluate the effectiveness of a Remote Ischemic Conditioning (RIC) programmable device for stroke recovery. Research has shown that RIC can aid recovery from neurological conditions, specifically improving recovery and reducing brain damage after a stroke. This treatment temporarily stops blood flow to one part of the body, which appears to protect the brain. Some evidence suggests that RIC might lower certain blood markers linked to heart damage and swelling, though this does not always lead to better long-term outcomes. While promising, more research is needed to fully understand how well RIC works for different types of strokes. Participants in this trial will receive either the RIC treatment or a sham RIC as part of the study's design. ^{1 2 3 4 6}

Who Is on the Research Team?

Aravind Ganesh, MD, DPhil

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.124.048976

Effect of Remote Ischemic Conditioning on the Form and ... This study aims to investigate whether RIC affects RBC deformability and levels of NO and nitrite in patients with ischemic stroke.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405580825002717

Research progress on remote ischemic conditioning for ... Clinical studies have confirmed that remote ischemic conditioning improves neurological recovery, reduces infarct volume, and enhances prognosis. However, the ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10548297/

Remote Ischemic Conditioning for Acute Stroke Among patients with acute stroke, RIC initiated in the prehospital setting and continued in the hospital did not significantly improve functional outcome at 90 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8576053/

Remote Ischemic Conditioning in Ischemic Stroke and ... We report evidence that RIC reduces circulating biomarkers of myocardial necrosis, infarct size, and edema, although this effect appears not to translate into ...

5. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(25)00140-3/fulltext

the REMOTE-CAT clinical trial The primary outcome was the proportion of patients with a favourable outcome (mRS <3) at 90 days. The intention-to-treat analysis included all ...

6. wellcomeopenresearch.org wellcomeopenresearch.org/articles/4-147

Self- or caregiver-delivered manual remote ischemic ... Conclusion: Both four and six cycles of short-term self- or caregiver-delivered RIC therapy is safe and may be feasible in acute ischaemic ...