Observational study on cardiovascular risk factors using non-invasive imaging
The Oxford Risk Factors And Non-Invasive Imaging Study
This study is trying to see if new imaging techniques can help doctors better understand and predict heart and metabolic diseases in patients getting CT scans.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250000 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of Oxford Academic / other |
| Locations | 37 sites (Bethesda, Maryland and 36 other locations) |
| Trial ID | NCT05169333 on ClinicalTrials.gov |
What this trial studies
The Oxford Risk Factors And Non-Invasive Imaging Study (ORFAN) is a prospective, multi-centre observational study aimed at developing and validating novel biomarkers for cardiometabolic diseases. It will collect CT scans, biological samples, and clinical outcomes data from unselected patients undergoing various CT scans at participating centers. By linking imaging data with patient demographics and clinical information, the study seeks to enhance diagnosis and risk prediction through advanced image analysis algorithms. Additionally, it will track disease progression and outcomes through follow-up scans and data collection.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 18 to 99 who are undergoing CT scans and can provide informed consent.
Not a fit: Patients with active cancer or those unable to consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic tools and risk assessment for cardiovascular diseases.
How similar studies have performed: Other studies utilizing similar imaging and biomarker approaches have shown promise, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Inclusion Criteria for study Arms 1, 2 and 3: * Participant is willing and able to give informed consent for participation in the study. * Male or Female, aged 18 -99 years. Inclusion Criteria for study Arm 4: • Male or Female, aged 18 -99 years. Exclusion Criteria: Exclusion Criteria for Study Arms 1, 2 and 3: * Unable or unwilling to consent * Active cancer Exclusion Criteria for Study Arm 4: * Participation in Study Arms 1, 2 or 3 * Existing opt-out from use of data for research purposes
Where this trial is running
Bethesda, Maryland and 36 other locations
- NIH National Heart, Lunch, and Blood Institute — Bethesda, Maryland, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Not_yet_recruiting)
- Cleveland Clinic Heart and Vascular Institute — Cleveland, Ohio, United States (Recruiting)
- Flinders University — Adelaide, Australia (Not_yet_recruiting)
- The University of Sydney — Sydney, Australia (Not_yet_recruiting)
- University Hospitals Leuven — Leuven, Belgium (Not_yet_recruiting)
- Fudan University — Shanghai, China (Not_yet_recruiting)
- TEDA International Cardiovascular Hospital — Tianjin, China (Not_yet_recruiting)
- Almaviva Sante - Clinique Axium — Aix-en-Provence, France (Not_yet_recruiting)
- Friedrich-Alexander-Universitat Erlangen-Nurmberg — Erlangen, Germany (Recruiting)
- University Hospital Ulm — Ulm, Germany (Not_yet_recruiting)
- Lefkos Stavros Clinic — Athens, Greece (Recruiting)
- MTA-SE Cardiovascular Imaging Research Group — Budapest, Hungary (Recruiting)
- Centro Cardiologico Monzino IRCCS, University of Milan — Milan, Italy (Recruiting)
- Oita University — Ōita, Japan (Recruiting)
- Amsterdam Universitair Medische Centra — Amsterdam, Netherlands (Not_yet_recruiting)
- Zuyderland Medical Centre — Sittard, Netherlands (Not_yet_recruiting)
- University of Medicine and Pharmacy of Targu Mures — Târgu Mureş, Romania (Recruiting)
- Seoul National University — Seoul, South Korea (Recruiting)
- Cleveland Clinic Abu Dhabi — Abu Dhabi, United Arab Emirates (Not_yet_recruiting)
- Royal United Hospitals Bath NHS Foundation Trust — Bath, United Kingdom (Recruiting)
- Sandwell and West Birmingham Hospitals NHS Trust — Birmingham, United Kingdom (Recruiting)
- University Hospitals Birmingham NHS Trust — Birmingham, United Kingdom (Not_yet_recruiting)
- Royal Papworth Hospital NHS Trust — Cambridge, United Kingdom (Recruiting)
- University of Edinburgh, Royal Infirmary — Edinburgh, United Kingdom (Not_yet_recruiting)
- Golden Jubilee National Hospital — Glasgow, United Kingdom (Not_yet_recruiting)
- NHS Greater Glasgow and Clyde — Glasgow, United Kingdom (Not_yet_recruiting)
- Leeds Teaching Hospitals NHS Trust — Leeds, United Kingdom (Recruiting)
- University Hosptials of Leicester NHS Trust — Leicester, United Kingdom (Recruiting)
- Liverpool Heart and Chest Hospital — Liverpool, United Kingdom (Not_yet_recruiting)
- Barts Health NHS Trust — London, United Kingdom (Recruiting)
- Guy's and St Thomas' NHS Foundation Trust — London, United Kingdom (Recruiting)
- Royal Brompton and Harefield Hospitals — London, United Kingdom (Recruiting)
- University Hospital of Manchester NHS Foundation Trust — Manchester, United Kingdom (Not_yet_recruiting)
- Milton Keynes University Hospital — Milton Keynes, United Kingdom (Recruiting)
- Oxford University Hospitals NHS Foundation Trust — Oxford, United Kingdom (Recruiting)
- Heart and Lung Centre, New Cross Hospital — Wolverhampton, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Antoniades — University of Oxford
- Study coordinator: Kenneth Chan
- Email: kenneth.chan@cardiov.ox.ac.uk
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.