Abstract
BACKGROUND: Early identification and treatment of stroke improve outcome. Ischaemic stroke due to large vessel occlusion (LVO) benefits from time-critical thrombectomy but this is only available in highly specialised healthcare services. Cerebral Bioimpedance Asymmetry (CBA) measurement obtained with the portable and rapid Cerebrotech Visor™ System device may be able to identify certain types of stroke including LVO. This test could be deployed pre-hospital and used to immediately direct patients to the most appropriate healthcare service for treatment. This study is evaluating the diagnostic accuracy of CBA measurements obtained from a real-world population of suspected stroke. METHODS: Study design: Prospective observational cohort study.Setting: A hyperacute stroke unit and neuroscience centre in North East England.Participants: Adults with a paramedic assigned diagnosis of suspected stroke arriving at hospital within 6 hours of symptom onset.Index Test: Cerebral Bioimpedance Asymmetry measurement performed using the Cerebrotech Visor™ System. Measurement values produce continuous data (range 0 -100); pre-defined threshold for positive state ≥ 10.Reference Standard Tests: Standard CT brain +/- CT/MR angiography, and expert clinician opinion will establish the following clinical outcomes which constitute the suspected stroke population: ischaemic stroke +/- large vessel occlusion; symptomatic severe anterior vessel stenosis; large (≥60ml) and small (<60mls) vessel intracerebral haemorrhage; transient ischaemic attack; stroke mimic conditions; prior territorial stroke.Analyses: Sensitivity, specificity, negative and positive predictive values, area under the Receiver Operating Characteristic curve for identification of i) "complex stroke" (ischaemic stroke with large vessel occlusion or symptomatic severe anterior vessel stenosis or intracerebral haemorrhage ≥60ml or prior territorial stroke) and ii) ischaemic stroke with large vessel occlusion in isolation.Sample size: 124 participants. DISCUSSION: The results from this study will determine how accurately CBA measurement using the Cerebrotech Visor™ System can identify key stroke types within the suspected stroke population. Acceptable diagnostic performance would be an important step forwards for access to time-critical treatments. TRIAL REGISTRATION: Registered with ISRCTN (identifier: ISRCTN79169844) on 06/08/2018.