Cardiovascular DiseasesORFANNCT05169333
The Oxford Risk Factors And Non-Invasive Imaging Study
An observational study of Cardiovascular Diseases and Cardiovascular Risk Factors, run by University of Oxford at 45 sites in 14 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cardiovascular Diseases, Cardiovascular Risk Factors
- How many people
- 250,000 participants
- Where
- 45 sitesin 14 countries
- Study dates
- 23 Feb 2016to Feb 2030
- How long will I take part?
- 15 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from secondary and tertiary NHS care providers in the UK and from international sites.
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 -99 years.
- Male or Female, aged 18 -99 years.
Who cannot join
- 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 locations and contacts
45 sites in 14 countries. Contact the study team or a site near you to ask about taking part.
Kenneth Chan, Dr contact
Ahmad Abdullrahman, Dr contact
45 sites in 14 countries
United Kingdom18 sites, 18 recruiting
- Recruiting
Royal United Hospitals Bath NHS Foundation Trust
Bath
- Recruiting
Sandwell and West Birmingham Hospitals NHS Trust
Birmingham
- Not yet recruiting
University Hospitals Birmingham NHS Trust
Birmingham
- Recruiting
Royal Papworth Hospital NHS Trust
Cambridge
- Not yet recruiting
University of Edinburgh, Royal Infirmary
Edinburgh
- Not yet recruiting
Golden Jubilee National Hospital
Glasgow
- Not yet recruiting
NHS Greater Glasgow and Clyde
Glasgow
- Recruiting
Leeds Teaching Hospitals NHS Trust
Leeds
- Recruiting
University Hosptials of Leicester NHS Trust
Leicester
- Not yet recruiting
Liverpool heart and chest hospital
Liverpool
- Recruiting
Barts Health NHS Trust
London
- Recruiting
Guy's and St Thomas' NHS Foundation Trust
London
- Recruiting
Royal Brompton and Harefield Hospitals
London
- Not yet recruiting
University Hospital of Manchester NHS Foundation Trust
Manchester
- Recruiting
Milton Keynes University Hospital
Milton Keynes
- Recruiting
The Newcastle Hospitals NHS Foundation Trust
Newcastle upon Tyne
- Recruiting
Oxford University Hospitals NHS Foundation Trust
Oxford
- Recruiting
Heart and Lung Centre, New Cross Hospital
Wolverhampton
United States12 sites, 12 recruiting
- Recruiting
Emory University
Atlanta, Georgia
De Cecco, Prof, carlo.dececco@emory.edu
- Recruiting
NIH National Heart, Lunch, and Blood Institute
Bethesda, Maryland
Mehta, Dr, nehal.mehta@nih.gov
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts
Blankstein, Prof, rblankstein@bwh.harvard.edu
- Recruiting
University of Virginia
Charlottesville, Virginia
Villines, Prof, tv4bc@uvahealth.org
- Recruiting
Cleveland Clinic
Cleveland, Ohio
Desai, Prof, desaim2@ccf.org
- Recruiting
UT Southwestern Medical Center
Dallas, Texas
Weber, Prof, Brittany.Weber@UTSouthwestern.edu
- Recruiting
Midwest Heart & Vascular Specialists LLC
Kansas City, Kansas
Bloom, Dr, Stephen.Bloom@HCAHealthcare.com
- Recruiting
St Luke's Hospital
Kansas City, Kansas
Centerp, Dr, Ehutt@saint-lukes.org
- Recruiting
Yale University, School of Medicine
New Haven, Connecticut
Evangelos, Dr, evangelos.oikonomou@yale.edu
- Recruiting
Valleywise Health
Phoenix, Arizona
Nordstrom, Dr, Lora.Nordstrom@valleywisehealth.org
- Recruiting
Brooke Army Medical Center (BAMC)
San Antonio, Texas
Gore, Dr
- Recruiting
Bridging Medical Silos
Tampa, Florida
Ho, Dr, nickho@bridgingmedicalsilos.com
Germany2 sites, 2 recruiting
- Recruiting
Friedrich-Alexander-Universitat Erlangen-Nurmberg
Erlangen
Marwan, Dr, Mohamed.Marwan@uk-erlangen.de
- Not yet recruiting
University Hospital Ulm
Ulm
Beer, Prof, meinrad.beer@uniklinik-ulm.de
Greece2 sites, 2 recruiting
- Recruiting
Lefkos Stavros Clinic
Athens
Benetos, Dr, benetosg@gmail.com
- Recruiting
National and Kapodistrian University of Athens - Hippokration Hospital
Athens
Tousoulis, Prof, drtousoulis@hotmail.com
Antonopoulos, Dr, alexios.antonopoulos@cardiov.ox.ac.uk
Italy2 sites, 2 recruiting
- Recruiting
Centro Cardiologico Monzino IRCCS, University of Milan
Milan
Pontone, Prof, gianluca.pontone@cardiologicomonzino.it
- Recruiting
Isola Tiberina-Gemelli Isola Hospital
Roma
Crea, Prof, filippo.crea@unicatt.it
La Vecchia, Dr, giulia.lavecchia@fbf-isola.it
Australia1 site, 1 recruiting
- Not yet recruiting
The University of Sydney
Sydney
Figtree, Prof, gemma.figtree@sydney.edu.au
Belgium1 site, 1 recruiting
- Not yet recruiting
University Hospitals Leuven
Leuven
De Bosscher, Dr, ruben.debosscher@uzleuven.be
Cyprus1 site, 1 recruiting
- Recruiting
Nicosia Polyclinic
Nicosia
Kadoglou, kadoglou.nikolaos@ucy.ac.cy
Denmark1 site, 1 recruiting
- Recruiting
GØdstrup Regional hospital
Aarhus
Winther, simowint@rm.dk
France1 site, 1 recruiting
- Recruiting
Assistance Publique - Hôpitaux de Paris
Paris
Redheuil, Prof, alban.redheuil@aphp.fr
Hungary1 site, 1 recruiting
- Recruiting
Semmelweis University
Budapest
Maurovich-Horvat, Prof, maurovich-horvat.pal@med.semmelweis-univ.hu
Romania1 site, 1 recruiting
- Recruiting
University of Medicine and Pharmacy of Targu Mures
Târgu Mureş
Benedek, Prof, theodora.benedek@gmail.com
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University
Seoul
Koo, Prof, bkkoo@snu.ac.kr
Taiwan1 site, 1 recruiting
- Recruiting
Taiwan Kaohsiung Medical University
Kaohsiung City
Lee, Prof, hclee@kmu.edu.tw
About this study
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.
Read the detailed description
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.
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Participants attending cardiology department, hypertension or outpatient clinics. | |
| Group 2 | 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. | |
| Group 3 | Individuals where at least 6 months have elapsed from previous CCTA will undergo repeat CCTA scan and enter prospective follow up for clinical endpoints. | |
| Group 4 | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 15 years
Secondary outcomes (5)
Cardiovascular risk factors
Using novel image analysis methods and blood biomarkers, to detect and monitor cardiovascular risk factors and responsiveness to routine clinical care
Measured: 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
Measured: 15 years
Genotyping
Using genotyping to predict clinical phenotypes
Measured: 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
Measured: 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
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start23 Feb 2016
- Primary completionFeb 2030 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 250,000 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Caristo Diagnostics Limited, Oxford University Hospitals NHS Trust, British Heart Foundation, Innovate UK, European Commission
- Responsible party
- Sponsor
- Investigators
- Charalambos Antoniades, Prof, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169333
- Sponsor's protocol ID
- The ORFAN Study
- Acronym
- ORFAN
- Status last verified
- Dec 2024
- First submitted
- 12 Oct 2021
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Westwood M, Armstrong N, Krijkamp E, Perry M, Noake C, Tsiachristas A, Corro-Ramos I. A cloud-based medical device for predicting cardiac risk in suspected coronary artery disease: a rapid review and conceptual economic model. Health Technol Assess. 2024 Jul;28(31):1-105. doi: 10.3310/WYGC4096.
PubMed 39023142
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Oxford Risk Factors And Non-Invasive Imaging Study
- ClinicalTrials.gov ID
- NCT05169333
- Acronym / sponsor ID
- ORFAN / The ORFAN Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250,000 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Caristo Diagnostics Limited, Oxford University Hospitals NHS Trust, British Heart Foundation, Innovate UK, European Commission
- Study start
- 23 Feb 2016 (actual)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 23 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 15 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Participants attending cardiology department, hypertension or outpatient clinics. |
| Group 2 | – | –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. |
| Group 3 | – | –Individuals where at least 6 months have elapsed from previous CCTA will undergo repeat CCTA scan and enter prospective follow up for clinical endpoints. |
| Group 4 | – | –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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from secondary and tertiary NHS care providers in the UK and from international sites.
Key inclusion criteria (3 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 -99 years.
- Male or Female, aged 18 -99 years.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiac and all cause mortality
Time frame: 15 years
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.
Non-fatal vascular events
Time frame: 15 years
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.
Cardiac and non-cardiac findings by Computed Tomography
Time frame: 15 years
Using novel image analysis methods, clinical risk factors, and blood biomarkers to detect pathology from Computed Tomography images.
Progression of disease
Time frame: 15 years
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.
5 secondary outcomes
Cardiovascular risk factors
Time frame: 15 years
Hospital admissions for any reason classified using ICD10
Time frame: 15 years
Genotyping
Time frame: 15 years
Progression of cardiovascular disease
Time frame: 15 years
Validation and refinement of the CaRi Image analysis platform
Time frame: 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Derived from this study: PubMed 39023142Westwood M, Armstrong N, Krijkamp E, Perry M, Noake C, Tsiachristas A, Corro-Ramos I. A cloud-based medical device for predicting cardiac risk in suspected coronary artery disease: a rapid review and conceptual economic model. Health Technol Assess. 2024 Jul;28(31):1-105. doi: 10.3310/WYGC4096.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kenneth Chan, Dr contact
Ahmad Abdullrahman, Dr contact
Charalambos Antoniades, Prof principal investigator
University of Oxford
45 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Cardiovascular Risk Factors, run by University of Oxford at 45 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United Kingdom, United States, Germany, Greece, Italy and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kenneth Chan, Dr (kenneth.chan@cardiov.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac and all cause mortality (time frame: 15 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05169333, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.