The Oxford Risk Factors And Non-Invasive Imaging Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cardiovascular Diseases, Cardiovascular Risk Factors. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Belgium, Cyprus, Denmark +9
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Cardiac and all cause mortality [Time frame: 15 years]
- Non-fatal vascular events [Time frame: 15 years]
- Cardiac and non-cardiac findings by Computed Tomography [Time frame: 15 years]
- Progression of disease [Time frame: 15 years]
Secondary outcome measures (5)
- 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]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 18 centers
- Royal United Hospitals Bath NHS Foundation Trust — Bath
- Sandwell and West Birmingham Hospitals NHS Trust — Birmingham
- University Hospitals Birmingham NHS Trust — Birmingham
- Royal Papworth Hospital NHS Trust — Cambridge
- University of Edinburgh, Royal Infirmary — Edinburgh
- Golden Jubilee National Hospital — Glasgow
- NHS Greater Glasgow and Clyde — Glasgow
- Leeds Teaching Hospitals NHS Trust — Leeds
- … and 10 more centers
United States · 12 centers
- Valleywise Health — Phoenix
- Yale University, School of Medicine — New Haven
- Bridging Medical Silos — Tampa
- Emory University — Atlanta
- Midwest Heart & Vascular Specialists LLC — Kansas City
- St Luke's Hospital — Kansas City
- NIH National Heart, Lunch, and Blood Institute — Bethesda
- Brigham and Women's Hospital — Boston
- … and 4 more centers
Germany · 2 centers
- Friedrich-Alexander-Universitat Erlangen-Nurmberg — Erlangen
- University Hospital Ulm — Ulm
Greece · 2 centers
- Lefkos Stavros Clinic — Athens
- National and Kapodistrian University of Athens - Hippokration Hospital — Athens
Italy · 2 centers
- Centro Cardiologico Monzino IRCCS, University of Milan — Milan
- Isola Tiberina-Gemelli Isola Hospital — Roma
Australia · 1 center
- The University of Sydney — Sydney
Belgium · 1 center
- University Hospitals Leuven — Leuven
Cyprus · 1 center
- Nicosia Polyclinic — Nicosia
Denmark · 1 center
- GØdstrup Regional hospital — Aarhus
France · 1 center
- Assistance Publique - Hôpitaux de Paris — Paris
Hungary · 1 center
- Semmelweis University — Budapest
Romania · 1 center
- University of Medicine and Pharmacy of Targu Mures — Târgu Mureş
South Korea · 1 center
- Seoul National University — Seoul
Taiwan · 1 center
- Taiwan Kaohsiung Medical University — Kaohsiung City
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. PMID 39023142
Identifiers
NCT: NCT05169333 · The ORFAN Study