OPERA
Research type
Research Study
Full title
Optimising a digital diagnostic pathway for Heart Failure in the community (OPERA)
IRAS ID
290441
Contact name
Clare Murphy
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
In Glasgow we will invite all patients on the HF diagnosis waiting list and offer them usual care heart failure diagnostic investigations (including ECG, standard echocardiography, blood tests and symptom questionnaires) at the Louisa Jordan Hospital. All patients will be sent a PIS inviting them to take part in a research project during their usual care appointment. Consenting participants will have an additional point of care (POC) echocardiogram and additional bloods taken as the research activity during the single visit.
The results of their usual care assessments will be available for their usual care cardiology team to review remotely and make an appropriate diagnosis (as would happen during a standard HF diagnosis referral). The cardiology team will generate a clinical report and recommended management plan and communicate with referring GP as standard of care.
The standard and POC echocardiography images will be anonymised and stored. A subsequent clinical investigation application to the MHRA will be submitted. Once awarded, anonymised images will be shared with US2.ai who will utilise novel AI analysis software (non-CE marked) to interpret. The CTU will compare the usual care BSE echocardiography report and the AI analysed report of both the standard and POC echocardiography images.
This study provides an additional opportunity to create a digital model that will simulate the NHSGGC HFDP service and thus facilitate digitisation of this service. Currently data are collected within this service in a non-systematic manner. Within the study, we will simulate a community-based digital platform that will standardise and improve the quality of data collected within this service and clinical care delivered by this service. The platform (STORM ID - ISO 13485 accredited) will have the potential to support clinicians to deliver clinical outcome reports following completion of HF investigations for people in the community who are being investigated for suspected HF.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
20/SW/0182
Date of REC Opinion
14 Dec 2020
REC opinion
Further Information Favourable Opinion