Topic: Stroke Research Network
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age > 18 years 2. Clinical stroke (lacunar or cortical) of ischaemic subtype 3. Within 12 hours of stroke onset 4. Arm and/or leg weakness at the time of randomisation
Exclusion criteria
Exclusion criteria: 1. Premorbid dependency, modified Rankin scale (mRS) >3 2. Known subclavian or brachial artery stenosis 3. Dementia 4. Coma [Glasgow Coma Scale (GCS< 8)] 5. Malignancy or significant comorbidity 6. Participation in other drug trials 7. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerability (duration cuff tolerated, number of cycles, drop out rate) and feasibility (accrual rate, proportion of patients knowing if they received RIC or sham) of RIC after hyperacute ischaemic stroke | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical safety (day 4±1, day 90±7): Serious adverse events (SAE); death (cause); recurrence/progression; neurological deterioration (increase in NIHSS >4 points); vascular events (including limb ischaemia, venous thrombo-embolism); neurovascular limb damage and tissue injury. Laboratory measures: (Day 0, day 4±1, day 90±7) Surrogate markers of efficacy, plasma S100B and MMP-9 levels by multiplex analysis; markers of inflammation and vascular function including but not limited to plasma CRP, e-selectin and vCAM by multiplex analysis; circulating endocannabinoids levels; plasma SOD activity by bioassay. Haemodynamic parameters: Transcranial Doppler (TCD), continuous recording during RIC, measures middle cerebral artery blood flow velocity/pulsatility index (a surrogate for cerebral blood flow (CBF)). Day 0 pre and post RIC, day 4±1 and day 90±7: central BP, pulse pressure, heart rate, rate-pressure product; aortic compliance and pulse wave velocity. Clinical efficacy: (Day 4±1, day 90±7) Impairment (NIHSS, motoricity index); dependency (modified Rankin Scale (mRS)); disability (Barthel Index(BI)<60)); functional independence (extended activities of daily living (EADL)); Zung depression scale; cognition (MMSE). At discharge/death: Length of stay in hospital; discharge disposition. | — |
Countries
United Kingdom