e-ASPECTS
Research type
Research Study
Full title
Ischaemic Stroke Image Evaluation using e-ASPECTS
IRAS ID
151567
Contact name
James S Hampton-Till
Contact email
Sponsor organisation
Anglia Ruskin University
Research summary
This study is an observational, multicentre, retrospective clinical study to carry out as validation of the e-Aspects software. It is designed to collect retrospectively pseudoanonymised data and CT images of up to 168 acute stroke patients who underwent CCT for symptoms of acute ischemic stroke and had brain imaging after 24 to 36 hours post treatment. Data from the software program will be compared to expert opinion. Brainomix has developed the medical imaging software e-ASPECTS that automatically analyses CT brain scans of stroke patients. The e-ASPECTS software will apply the clinically validated Alberta Stroke Program Early CT score (ASPECTS) method, thereby, automatically assessing and quantifying early ischemic brain damage on CT scans of acute stroke patients.
Patients with stroke symptoms should be diagnosed and selected for treatment as early as possible. This should be carried out by a consultant neuroradiologist taking into account the patients; CT scans. However, the majority of hospitals worldwide do not have 24/7 access to a neuroradiologist. Although the ASPECTS score has been extensively validated in clinical studies, the significant experience required by the medical professional to utilise it has been so far a rapid, quick and accurate assessment of the patients; condition, irrespective of his/her experience or specialism. Eligible patients will be asked retrospectively for the use of their pseudoanonymised personal data and CT scans. In case retrospective data collection cannot be achieved, it will include prospective data on an ongoing basis. data from the software evaluation will be tested for non-inferiority against expert assessment and evaluated by an independent core laboratory. Patient's functional status will also be collected pre-admission and at 6 weeks and if available at three months by the mRs.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
14/EE/1025
Date of REC Opinion
25 Jun 2014
REC opinion
Further Information Favourable Opinion