The Oxford Risk Factors And Non-invasive imaging Study

• Research type

  Research Study

• Full title

  The Oxford Risk Factors And Non-invasive imaging Study

• IRAS ID

  164361

• Contact name

  Charalambos Antoniades

• Contact email

  antoniad@well.ox.ac.uk

• Sponsor organisation

  University of Oxford / Clinical Trials and Research Governance

• Duration of Study in the UK

  15 years, 0 months, 0 days

• Research summary

  ORFAN is a multi-centre cohort observational study involving patients undergoing computed tomography angiography (CTA) or who have had a CTA or CT chest, abdomen and pelvis scan in the past and patients attending outpatient clinics.
  The study has two main objectives:

  1) To investigate whether biomarkers of metabolic risk can predict major adverse cardiovascular events
  2) To identify novel biomarkers able to predict cardiovascular disease pathogenesis and extent of pre-existing vascular disease

  The study consists of 4 Arms.
  Arms 1, 2 and 3 with a total of 15,500 participants will be prospectively consented to address objectives 1 and 2. The outcome data of these participants are collected through NHS digital with whom a data sharing agreement has been singed already (DARS-NIC-392669-T1F8B).

  Arm 4 is a retrospective arm, which includes further 100,000 participants (75,000 - in the UK; 15,000 - internationally) who have undergone CT chest, abdomen and pelvis scans. This study arm focuses on collecting CT images, patient demographics, clinical information including outcomes to aid the development of new image analysis algorithms and software tools (using artificial intelligence and other approaches) to allow automation of the image analysis processes (such as the automated calculation of Fat Attenuation Index) used in Arms 1-3. This study arm will grant us the statistical power to use artificial intelligence based statistical approaches to address our study objectives.

  Following the COVID-19 pandemic, the ORFAN study programme has been designated by the NIHR and the British Heart Foundation as a National Flagship programme in our concerted efforts to study and treat the disease. We will specifically ascertain COVID-19 status (suspected or confirmed) for arms 2, 3 and 4. The influence of COVID-19 infection on the outcome measures of the study will be explored.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  15/SC/0545

• Date of REC Opinion

  4 Nov 2015

• REC opinion

  Further Information Favourable Opinion