The Oxford Risk Factors And Non-Invasive Imaging Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorUniversity of Oxford
About this trial
ORFAN is a prospective, multi-centre, multi-ethnic cohort observational study collecting CT scans, biological material and outcomes data, to develop and validate novel biomarkers of cardiometabolic and other disease risk.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant is willing and able to give informed consent for participation in the study.
Male or Female, aged 18 -99 years.
Disqualifiers
Unable or unwilling to consent
Active cancer
Participation in Study Arms 1, 2 or 3
Existing opt-out from use of data for research purposes
Trial population
Patients will be recruited from secondary and tertiary NHS care providers in the UK and from international sites.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
250,000 Participants
are grouped into 4 trial groupsGroup A: Group 1
Group B: Group 2
Group C: Group 3
Group D: Group 4
Trial outcomes
Primary outcomes
1
Cardiac and all cause mortality
Using novel image analysis methods, clinical risk factors, and blood biomarkers to predict future cardiac and all-cause mortality over a period of 15 years post CT scan.
Time frame
15 years2
Non-fatal vascular events
Using novel image analysis methods, clinical risk factors, and blood biomarkers to predict future non-fatal vascular events over a period of 15 years post CT scan.
Time frame
15 years3
Cardiac and non-cardiac findings by Computed Tomography
Using novel image analysis methods, clinical risk factors, and blood biomarkers to detect pathology from Computed Tomography images.
Time frame
15 years4
Progression of disease
Using novel image analysis methods, clinical risk factors, and blood biomarkers to predict progression of cardiometabolic diseases over a period of 15 years post index CT scan.
Time frame
15 yearsSecondary outcomes
1
Cardiovascular risk factors
Using novel image analysis methods and blood biomarkers, to detect and monitor cardiovascular risk factors and responsiveness to routine clinical care
Time frame
15 years2
Hospital admissions for any reason classified using ICD10
Using novel image analysis methods, to predict hospital admissions over a period of 15 years post CT scan
Time frame
15 years3
Genotyping
Using genotyping to predict clinical phenotypes
Time frame
15 years4
Progression of cardiovascular disease
Using novel image analysis methods, clinical risk factors, and blood biomarkers to predict disease progression measured by CT scans
Time frame
15 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Oxford
Lead sponsor
Caristo Diagnostics Limited
Collaborator
Oxford University Hospitals NHS Trust
Collaborator
British Heart Foundation
Collaborator
Innovate UK
Collaborator
European Commission
Collaborator
Source ClinicalTrials.gov