An observational study in Cardiovascular Diseases and Cardiovascular Risk Factors, sponsored by University of Oxford. Recruiting at 45 sites in 14 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by University of Oxford · Observational
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.
The ORFAN registry will include unselected, consecutive patients undergoing CT scans (coronary CT angiograms (CCTA), CT chest, abdomen and pelvis scans) collected at the participating centres. The study will combine imaging data with patient demographics and clinical information (including prospective outcomes) to aid the development and/or validation of new or existing image analysis algorithms and software tools to improve diagnosis, clinical risk discrimination and prediction. Specifically, ORFAN will evaluate the specificity, utility and predictive value of newly developed image analysis methods. ORFAN will recruit and follow-up patients prospectively, linking the index CT scan with blood biomarkers, genetic information as well as information on disease progression (recorded through follow-up CT scans) and clinical outcomes data.
The study will also collect CT scans performed in the past and link them with clinical factors and prospective outcomes data collected after the index scan was performed.
5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.
This study's planned enrollment of 250,000 is above the median of 506 across 1,572 observational studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients will be recruited from secondary and tertiary NHS care providers in the UK and from international sites.
Inclusion Criteria:
Inclusion Criteria for study Arms 1, 2 and 3:
Inclusion Criteria for study Arm 4:
Exclusion Criteria:
Exclusion Criteria for Study Arms 1, 2 and 3:
Exclusion Criteria for Study Arm 4:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants attending cardiology department, hypertension or outpatient clinics.
Participants who are recruited prospectively, during their clinically indicated CT scan, and they are followed-up prospectively for clinical endpoints; A follow-up CCTA at least 6 months later will be offered to a subgroup of these patients, to assess disease progression.
Individuals where at least 6 months have elapsed from previous CCTA will undergo repeat CCTA scan and enter prospective follow up for clinical endpoints.
Cohort of consecutive patients who have undergone clinical CTAs or unenhanced CT chest, abdomen and pelvis in the past, linking the index CT scan with prospective outcomes collection already accumulated.
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 years
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 years
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 years
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 years
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 years
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 years
Genotyping
Using genotyping to predict clinical phenotypes
Time frame: 15 years
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 years
Validation and refinement of the CaRi Image analysis platform
Validate the prognostic and diagnostic performance of CaRi Image analysis platform against the other study outcomes
Time frame: 15 years
Started Feb 2016 (actual). Primary completion is estimated for Feb 2030, 168 months after the start.
Of 580 non-industry observational studies under Cardiovascular Diseases, half reached primary completion within 70 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 196. This study's planned 168 months is above that.
Counting every sponsor, half of 664 studies reached it within 61 months; a quarter within 24 and three quarters within 192.
Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
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