Validation study for introduction of novel computed tomography Imaging biomarkers in clinical Practice
Study Background
Our research group has recently discovered a new way of analysing pictures of the heart from computed tomography (CT) scans that can identify people at risk of having a heart attack, years in advance. This technology, called Fat Attenuation Index, has received extensive publicity: see articles in Financial times; BBC News, NBC, Guardian, and others), while the recent results were featured in lay press (see Reuters, Independent, Sky News, The Times, Daily Mail and others). This technology has been presented by iNews as one of the top 10 innovations that will make it into the NHS in the coming years. More details in the technology we are using for this project, can be found in this video link.
Study Objectives
We are planning a new study, to explore the effect of the different CT scanner types and the impact on the various technical parameters of the scan, on the new biomarkers, as well as to understand how they correlate with established biomarkers in the blood. We will therefore ask each participant to have a minimum of two CT scans, so we can compare their images between different scanners.
Study Recruitment
This study aims to recruit 90 participants to undergo two CT scans over a period of two weeks. The study is actively recruiting until 2022 and will follow participants up until 2023.
As part of our PPI (Patient and Public Involvement) initiative participants can review study documents and give feedback on how to improve future ethically approved clinical studies.
Study Visits
Each participant must undergo one study visit at the Manor Hospital in Oxford (Nuffield Health) as this is our reference site/scanner along with a second study visit at one of our other study sites in either Oxford (OUH Trust), Leicester (University Hospitals of Leicester) or London (Royal Brompton and Harefield NHS Foundation Trust). Each visit is expected to last no longer than one hour, and participants will be reimbursed for their time (£50/visit) plus for any travel expenses.
All participants will sign a consent form and allow us to collect a brief medical history on their first study visit; this should last no more than 15 minutes. We will then carry out the research coronary CT angiogram which is approximately 30 minutes.
The second study visit will either be at the Manor Hospital again (10 participants will have a repeat scan here) and the remaining participants will be required to visit a different hospital site in either Leicester, London or elsewhere in Oxford. Full details can be found in the VIP Participant Information Sheet. If a coronary CT angiogram was recently performed as part of clinical care, then a second scan may not be needed, and the existing images from the recent scan can be used instead.
Study Investigators
Prof C Antoniades (CI) 1, Dr Elsa Mauricio Reus1, Ms Sheena Thomas1, Dr Ed Nicol2, Dr David Adlam3, Dr Amrita Bajaj3, Dr Aparna Deshpande3, Dr Praveen Rao3, Dr Das Indrageet3, Dr Saeed Mirsadraee2, Dr Tarun Mital2, Prof Keith Channon1, Dr Suzie Anthony⁵, Prof Stefan Neubauer1, Dr Cheerag Shirodaria4, Dr Dan Green4.
- Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford
- Royal Brompton & Harefield NHS Foundation Trust
- University Hospitals of Leicester
- Caristo Diagnostics Limited
- Oxford University Hospitals NHS Trust
Research Funding
This study is funded by an Innovate UK grant, awarded collaboratively between the University of Oxford, University of Leicester, Royal Brompton and Harefield NHS Foundation Trust and Caristo Diagnostics.
Study Approval
This study has been approved by South Central – Oxford A Research Ethics Committee (Ethics Reference: 11/SC/0273).
The Oxford Cohort for Heart, Vessels & Fat 