A blood pressure cuff inflated on the arm in short, repeated cycles could improve recovery for people having a stroke. Stroke strikes someone in the UK every five minutes, often leaving survivors with lasting disability, and costs the NHS roughly £9 billion each year. The technique, called remote ischaemic conditioning (RIC), works by briefly cutting off blood flow to the arm, which triggers the body to release protective proteins that may shield the brain from further injury. This Phase III trial will test RIC against a sham procedure in 1,300 patients treated within six hours of stroke onset across 60 UK emergency departments. If RIC proves effective, it would offer a cheap, simple, and portable treatment—anyone from a paramedic to a nurse could administer it with minimal training. Better functional outcomes would mean more stroke survivors regain independence, reducing the physical, psychological, and financial burden on patients, carers, and the NHS. The trial also includes substudies using brain scans to understand exactly how RIC protects brain tissue, which could guide future treatments.
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Hypothesis: Remote ischaemic perconditioning (RIC) improves functional outcome in patients presenting with hyperacute stroke. Background: Stroke is common with one stroke occurring in the UK every 5 minutes. It can be devastating to patients and carers, and costs the NHS ~£9 billion/year. Remote ischaemic conditioning (RIC) uses repeated cycles of transient limb ischaemia and, experimentally, can help protect the brain from injury. It can be performed before (preconditioning), during (perconditioning) or after (postconditioning) an ischaemic insult by inflating & deflating a blood pressure cuff on the arm. We have completed a pilot trial (RECAST) showing RIC is well tolerated after acute stroke and augments serum levels of neuroprotective proteins (heat shock proteins, HSP). RECAST-2, a phase IIb study, has demonstrated feasibility of repeated doses of RIC in hyperacute stroke (<6 hours). Aim: To perform a multicentre randomised controlled trial assessing remote ischaemic conditioning (RIC) in patients with hyperacute ischaemic stroke. Design: Phase III prospective randomised (1:1) sham-controlled blinded-endpoint parallel-group multicentre trial. Population: 1300 adults with hyperacute ischaemic stroke presenting to 60 Emergency Departments and Stroke Units in the UK. Intervention: RIC group: 4 cycles of intermittent limb ischaemia - alternating 5 minutes inflation (+20 mmHg above systolic BP) followed by 5 minutes deflation of an automated upper arm blood pressure cuff. Comparator: Sham RIC. An automated upper arm blood pressure cuff is inflated to 20 mmHg for 4 cycles (5minutes inflation/5 minutes deflation). Treatment Duration: 1st dose (4 cycles of RIC or sham) within <6 hours of onset. Second dose 1-2 hours after the first dose. Twice daily until end day 2; total 4 doses. Primary outcome: Death or dependency at day 90 (modified Rankin Scale [mRS], ordinal shift analysis) recorded using central blinded telephone follow-up. Secondary outcomes (day 90): Cerebrovascular events; major adverse cardiac and cerebral events; acute kidney injury; disability; cognition; mood; frailty; quality of life; safety (death; neurological deterioration; intracranial haemorrhage, systemic embolism, serious adverse events). Sample size: Assuming alpha=0.05, power=90%, losses to follow up=5% and covariate adjustment reducing sample size by 20%, a sample size of 1300 will be needed to detect a treatment effect of OR 0.75 by shift analysis of mRS. Mechanisms: Ischaemic reperfusion injury (Day 2 CT brain: intracranial haemorrhagic, swelling of original stroke, recurrent ischaemic stroke); mechanical thrombectomy substudy (Day 7 MRI; infarct growth and volume, oedema, perfusion). Timeframe: 45 months (M) with 33M recruitment in 60 centres. M0-6: trial set up, centre initiation & training (site initiation will be performed over the telephone); M3-36: recruitment; M37-39: Final day 90 Follow-ups (primary outcome); M40-45: Data clean & lock, analysis & dissemination Impact: Improvements in functional outcome after a stroke will benefit patients in promoting independence and decreasing care needs in terms of physical, psychological and carer burden. RIC is an attractive prospect since it would be cheap & simple to administer by medics, allied health professionals, or non-medically qualified personnel.
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