Abstract
BackgroundEarly 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.MethodsStudy 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 participantsDiscussionThe 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 registrationRegistered with ISRCTN (identifier: ISRCTN79169844) on 06/08/2018.
Highlights
Identification and treatment of stroke improve outcome
The cause of stroke is either cerebral ischaemia (85%) or haemorrhage (15%) and all patients benefit from urgent admission to organised multidisciplinary stroke care [3], there is strong evidence that two emergency reperfusion treatments for ischaemic stroke significantly reduce long-term disability: intravenous thrombolysis [4, 5] and intra-arterial mechanical thrombectomy [6]
To determine the diagnostic accuracy of Cerebral Bioimpedance Asymmetry (CBA) measurement performed using the Cerebrotech VisorTM System (CVS) to identify large vessel occlusion (LVO) in patients arriving at a hospital with a paramedic assigned diagnosis of suspected acute stroke
Summary
To determine the diagnostic accuracy of CBA measurement performed using the CVS to identify complex stroke (ischaemic stroke with LVO or SSAVS or LICH ≥ 60 ml in volume or PTS) in patients arriving at a hospital with a paramedic assigned diagnosis of suspected acute stroke. Ischaemic stroke due to LVO will be defined as present if CT or MR angiography has been conducted and demonstrates reduced filling in any large branch of the anterior cerebral circulation This will be assessed and recorded by a neuro-radiologist blinded to patient and study information using the Ten Point Clot Burden Score [24]. Expert clinician diagnosis defined outcome states As no single test exists for ischaemic stroke without LVO, transient ischaemic attack (TIA) and mimic conditions, expert clinician opinion informed by brain imaging +/− other investigations as appropriate will be used as the reference standard. All such events will be considered ‘unexpected’ and reported to the chief investigator, study sponsor and Research Ethics Committee
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