Rapid Ambulance Diagnosis Of Stroke (RADIOS)
Research type
Research Study
Full title
Rapid Ambulance Diagnosis Of Stroke (RADIOS): a pre-hospital feasibility study
IRAS ID
332951
Contact name
Elizabeth Warburton
Contact email
Sponsor organisation
Pockit diagnostics Ltd
Duration of Study in the UK
0 years, 4 months, 13 days
Research summary
Around 25% of ischaemic strokes are caused by large vessel occlusion (LVO) e.g. a large thrombus blocking a major cerebral artery and therefore blood supply to the brain. Clinicians can now retrieve these clots using a technique called mechanical thrombectomy (MT). National and international guidance advocate its use in the first 6 hours of stroke, but up to 24 hours in specialist cases. The problem is that MT is only carried out in specialist centres and that it can be difficult to diagnose clinically, without the use of brain imaging. Therefore, valuable time can be wasted if a patient with LVO does not immediately arrive at a MT centre, as the earlier they receive treatment, the higher the chance of avoiding disability and death. Supported by public funding, Upfront DX developed LVOne, a portable point-of-care blood test which could be quickly deployed to detect LVO with high accuracy.
LVOne has been demonstrated to detect LVO within 15 minutes with 92% specificity, 78% sensitivity, and an overall accuracy of 90%. A positive result will direct ambulances towards a regional centre instead of any nearer stroke unit without MT. This study is to establish the usability and feasibility of the LVOne test when in the hands of ambulance paramedics. LVOne test will be used on prospective patients who are evaluated for suspected stroke by paramedics. Patient data will be collected to ensure that the study is conducted on the intended use population and paramedics opinions on the use of the LVOne in a real clinical setting will be collected. For the test to be used in clinical practice there is a regulatory requirement to demonstrate its use in the desired population and expected clinical settings.
The data generated will be used to obtain UKCA and CE marking so that the product could be placed on the market.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
24/EE/0057
Date of REC Opinion
7 May 2024
REC opinion
Further Information Favourable Opinion