Remote Ischaemic Conditioning After Stroke Trial (ReCAST-2) "ReCAST-2"

Recruiting

Phase 2 Results N/A

Trial Description

Stroke has an enormous impact on both individual and society. Novel treatments are required to relieve this burden and remote ischaemic conditioning (RIC) is one such approach. RIC refers to applying non-lethal ischaemia to an area distant from an organ you are trying to protect (e.g. the brain). Pre-clinical animal stroke studies have shown RIC to be neuroprotective and help restore functional outcome when compared to control. These outcomes are achieved simply by transiently occluding the blood supply to a limb (e.g. the arm) very soon after the stroke occurs. The mechanisms of protection are unclear but may be due enhancing the body's ability to protect itself from further injury by favorably altering cerebral blood flow or reducing the detrimental effects of oxygen free radicals. Ischaemic conditioning (IC) is an intervention already applied during cardiac surgery to protect the heart from damage and it may be effective after an acute myocardial infarction. The investigators therefore plan to conduct a pilot randomised controlled trial assessing the feasibility of applying RIC (4 cycles of blood pressure cuff inflation for 5 minutes) in patients within 6 hours of ischaemic stroke. The primary outcome is feasibility of RIC. Secondary outcomes include tolerability, safety and clinical efficacy. The results will inform the design of future trials of a potential intervention is that is pragmatic, non-invasive and simple to administer.

Conditions

Interventions

  • Sham Device
    Intervention Desc: 4 cycles of intermittent sham procedure (1 cycle = 5 minutes inflation to 30 mmHg, 5 minutes deflation), matching the dose escalation described in the intervention
    ARM 1: Kind: Experimental
    Label: Control
    Description: Control: 4 cycles of alternating 5 minutes inflation (up to 30 mmHg) followed by 5 minutes deflation of a standard upper arm blood pressure cuff
  • Remote ischaemic conditioning Procedure
    Intervention Desc: 1 dose (=4 cycles) of intermittent upper limb ischaemia (1 cycle = 5minutes inflation to 20mmHg above systolic BP, 5 minutes deflation). Dose escalation: (i) Recruits 1-20 receive this cycle once (ii) Recruits 21-40 receive a second dose of 4-cycles one hour after the first. (iii) Recruits 41-60 receive further dosing, twice daily until day 4.
    ARM 1: Kind: Experimental
    Label: Remote Ischaemic Conditioning
    Description: Remote ischaemic conditioning (RIC group): 4 cycles of intermittent limb ischaemia - alternating 5 minutes inflation (20mmHg above systolic BP) followed by 5 minutes deflation of a standard upper arm blood pressure cuff

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Trial feasibility 90 days No
Secondary Vascular Event Rate [Safety and Tolerability] Day 1, Day 4±1, day 90±7 Yes
Secondary Treatment Related Serious Adverse Event Rates [Safety and Tolerability] Day 1, Day 4±1, day 90±7 Yes
Secondary Biomarkers Immediately before RIC/sham at baseline; immediately after RIC/sham on Day 1; day 4±1 No
Secondary Impairment Day 4±1, day 90±7 No
Secondary Dependency Day 90±7 No
Secondary Disability Day 90±7 No
Secondary Mood Day 90±7 No
Secondary Telephone cognition Day 90±7 No

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