The ORFAN study

The Oxford Risk Factors And Non Invasive Imaging Study (ORFAN)

Study Background

Research has shown that obesity is a known risk factor for cardiovascular disease (CVD) and increased body fat is associated with a higher risk for heart disease. In this study we are aiming to show that it is not only the amount of fat a person has in their body but also the characteristics of the fatty tissue that is just as important for assessing the risk of developing CVD.

In order to characterise the fatty tissue (adipose tissue), we use computed tomography (CT) as a non-invasive and accurate method. We look at the fat beneath the skin and the fat that sits around the heart and coronary vessels.

What is being studied?

The purpose of the ORFAN Study is to find a way to predict a person’s likelihood of having a cardiovascular event such as a heart attack or stroke in the future by crosslinking the information gathered from CT images of the body adipose tissue and biomarkers in the blood. Furthermore, in this study we also would like to find out whether the biomarkers in the blood can be used to predict progression of cardiovascular disease.

Study Recruitment

A total of 15500 participants (aged between 18-99 years) will be recruited prospectively into study Arms 1-3. These are individuals who have attended a cardiac outpatient clinic (n=500) or have been asked by their clinical care team to undergo a cardiac CT scan at various participating hospital NHS sites throughout the UK (n=10,000) or they have previously had a clinical cardiac CT scan at least 6 months before they are enrolled into the study (n=5000). All participants in study Arms 1-3 provide written informed consent for their participation to the study.

In study Arm 4, we are aiming to include 250,000 individuals who have undergone CT scans (cardiac, chest, abdomen or pelvis) from 2010 onwards in any of the participating sites. Clinical information, demographic characteristics as well as the CT scans are collected from the local hospital records, while prospective outcomes data are collected via several sources, including national registries where appropriate. This study arm aims to to develop new image analysis algorithms and software tools (using artificial intelligence and other approaches) to allow automation of the image analysis processes. De-Personalised data from the UK sites are collected under Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 – s251, while for non-UK sites data is collected from the local clinical care teams and deposited into the study in a fully anonymised way, following site-specific individual ethical approvals.

ORFAN is part of the Oxford cohort for Heart, Vessels and Fat (Ox-HVF), which means the results from this study are interpreted together with the findings of other Ox-HVF projects. The Ox-HVF cohort is a cluster of clinical studies that together provides results allowing the deployment of a multi-level strategy to understand the mechanisms of cardiovascular disease. This will add value to the research results and potentially allow the translation of the findings into clinical applications.

Study Visits

All participants will have their first CT scan at one of the radiology departments of the various participating NHS sites as part of their routine clinical care (Study arms 2-3). In those participating in study Arm 2, a blood sample will be taken for research purposes to measure for blood biomarkers.
For patients in study arms 2 and 3, a second CT scan will be scheduled at least 6 months after the initial scan at one of the CT scanners within the selected NHS sites. At this visit another CT scan will be performed and a blood sample will be taken. Study investigators will then be able to make comparisons between the two sets of images and blood samples (where applicable) to see if there have been any changes overtime.

Study follow up

For participants in Study Arms 1-3, a follow up phone call will be made to each participant every 2 years for a total of 10 years to complete a health questionnaire. These participants may be contacted in the future for possible participation in future ethically approved studies, if they have explicitly agreed for this to happen at the time of their informed consent.

Further clinical information including the original CT scans performed as part of clinical care, will be obtained from the local hospital records for all study arms participants. Prospective follow up will be performed for all study participants via local and national registries, for a period of at least 10 years after their original CT scan.

Full details of the study and study visits will be explained to potential participants in the study information leaflet.

Study Investigators

Prof Charalambos Antoniades (CI), Prof Keith M Channon, Dr Alexios Antonopoulos, Ms Sheena Thomas, Ms Maria Lyasheva, Dr Evangelos Oikonomou, Dr Nikant Sabharwal, Dr Cheerag Shirodaria, Dr Raman Uberoi, Dr Susan Anthony, Prof. Adrian Banning, Dr Andrew Kelion, Dr Attila Kardos, Dr Ed Nicol, Dr David Adlam, Dr Jonathan Rodrigues, Dr Benjamin Hudson, Prof John Greenwood, Prof Colin Berry and Prof Stefan Neubauer

Research Funding

The study is supported with funding from the Oxford Biomedical research Centre, The British Heart Foundation, Innovate UK, the National Consortium for Intelligent Medical Imaging and the European Commission.

 

Study Approval

The study has been approved by the South Central – Oxford C Research Ethics Committee (Reference 15/SC/0545). Further approval for collection of pseudoanonymised data from the UK sites was obtained under the Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 – s251 – (Confidentiality Advisory Group Ref: 20/CAG/0157).

Study dashboard:

Announcements for study participants:

Announcement 23/8/2016: Where it states in the consent form ‘I understand that long term health outcome data will be collected by study investigators by securely accessing records held with the NHS, Health and Social Care Information Centre (HSCIC) ‘ we would like to inform participants that the HSCIC has now changed its name to NHS Digital.