Abstract Body: Introduction:
Remote ischaemic per-conditioning(RIC) in experimental ischaemic stroke(IS) is cytoprotective and may reduce ischaemic reperfusion injury. It is achieved by repeated transient occlusion of the blood supply to a limb using a blood pressure cuff(BP-cuff). We aim to assess RIC in patients with acute ischaemic stroke(AIS), whether RIC is safe and improves functional outcome in AIS patients.
Methods:
RECAST-3 is a prospective randomised controlled blinded-endpoint parallel-group multi-centre trial. 1300 adults(≥18-years) with AIS, ≤24-hours post-onset, characterised by NIHSS score(5-25) without spontaneous ICH on baseline-neuroimaging in the UK will be recruited.
Exclusion criteria include pre-morbid dependency (mRS>3), spontaneous ICH, systolic BP<80mmHg, HTI(PH2), pre-existing diagnosis of dementia, GCS<8, malignancy, life-expectancy<6-months, BM<3.0mmol/L, known pregnancy, seizure on presentation, significant tissue injury of the upper limbs, expected repatriation of the participant to non-participating hospitals in RECAST-3.
Participants will be randomised(1:1) to receive doses of either RIC (4-cycles alternating between 5-minutes inflation to 20mmHg above systolic BP and 5-minutes deflation of bilateral upper arm BP-cuffs); or sham (4-cycles alternating between 5-minutes inflation to 50mmHg and 5-minutes deflation of bilateral upper arm BP-cuffs) administered twice daily for a total of 14-days (28-doses).
Results
The primary outcome is death or dependency at day 90 (ordinal shift-analysis in the mRS) recorded using central blinded telephone follow-up. Secondary outcomes include cerebrovascular events, major adverse events (cardiac/cerebral), disability, cognition, mood, frailty, QoL, and safety.
Conclusions
RECAST-3 will provide evidence for the use of RIC in AIS. The results will inform on the safety and improvement of functional outcomes in patients for standardised practice in AIS treatment.