Testing of a System for Remote Ischemic Conditioning in Cerebral Small Vessel Disease and Pre-hospital Stroke Care

NCT05967728 | Enrolling By Invitation Phase 2

• 1 other identifier: Version 1.0
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This early phase trial will address the following key objectives:

1. 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. 2.Usability testing of the prototype with patients and healthcare professionals, with further optimization.

Conditions

Cerebral Small Vessel Diseases; Cerebral Small Vessel Ischemic Disease; Ischemic Stroke; Vascular Cognitive Impairment; Stroke, Acute

Keywords

Remote ischemic conditioning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Discontinuation

  60 days for patients with CSVD

• Pain or discomfort

  30 days and 60 days for patients with CSVD

Study Arms (2)

Remote Ischemic Conditioning (RIC)

EXPERIMENTAL

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.

Device: Remote ischemic conditioning (RIC) progammable device

Sham RIC

SHAM COMPARATOR

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.

Device: Remote ischemic conditioning (RIC) progammable device

Interventions

Remote ischemic conditioning (RIC) progammable device DEVICE

RIC induces brief periods of ischemia-reperfusion in a limb. In our study, this is accomplished using a new device that can be remotely programmed to deliver either true RIC or a sham protocol, with remote monitoring capabilities to track completion of treatment sessions.

Also known as: Ischemic preconditioning (for the CSVD patients), Ischemic postconditioning (for the stroke patients), Ischemic perconditioning (for the stroke patients)

Remote Ischemic Conditioning (RIC); Sham RIC

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For patients with Cerebral Small Vessel Disease (CSVD):
• Age ≥18 years
• 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(21) 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:
• Age ≥18 years
• Evaluated in the Mobile Stroke Unit
• Diagnosed as having an acute ischemic stroke (all MSU code stroke activations during the study will be tracked)

You may not qualify if:

• 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)
• Any vascular, soft-tissue, or orthopedic injury that in the physician's opinion contraindicates arm ischemic preconditioning
• History of peripheral vascular disease, such as subclavian or other upper limb arterial stenosis or occlusion
• 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
• Any vascular, soft-tissue, or orthopedic injury that in the physician's opinion contraindicates arm ischemic preconditioning
• History of peripheral vascular disease, such as subclavian or other upper limb arterial stenosis or occlusion

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, T3R1B9, Canada

Location

Related Publications (1)

• 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.

  PMID: 36354025 BACKGROUND

MeSH Terms

Conditions

Cerebral Small Vessel Diseases; Ischemic Stroke; Stroke

Interventions

Ischemic Preconditioning; Ischemic Postconditioning

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Officials

• Aravind Ganesh, MD, DPhil

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: For the study component involving patients with CSVD, we will aim to achieve double blinding of the patients, care providers, and the outcome assessors regarding the initial randomization to RIC treatment or sham for the first 30 days. This will be achieved in two important ways: (1) the same device can be randomized to sham or control, so it will appear identical to the patient and to the assessors, and (2) the device randomization to sham or control will be implemented remotely through a platform that can program the devices, which will be inaccessible to the outcome assessors. The study components involving MSU patients and physicians/paramedics will not involve blinding.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Vascular and Cognitive Neurologist

Model Details: The randomized-controlled trial component of the study will involve 24 patients with CSVD, randomized 1:1 to either receive RIC for the full 60-days, or sham treatment (inflation to 30mmHg) for the first 30-days followed by cross-over to RIC. The MSU-based component of the study, consisting of 10 patients with acute ischemic stroke, will not involve randomization and all participants will be receiving true RIC.

Study Record Dates

• First Submitted: June 25, 2023
• First Posted: August 1, 2023
• Study Start: December 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)