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

NCT05967728 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-12-31

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DEVICE

Remote ischemic conditioning (RIC) progammable 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.

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Aravind Ganesh, MD, DPhil · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05967728 on ClinicalTrials.gov