The Oxford Risk Factors And Non-Invasive Imaging Study
- Conditions
- Cardiovascular DiseasesCardiovascular Risk Factors
- Registration Number
- NCT05169333
- Lead Sponsor
- University of Oxford
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250000
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:
โข Male or Female, aged 18 -99 years.
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cardiac and non-cardiac findings by Computed Tomography 15 years Using novel image analysis methods, clinical risk factors, and blood biomarkers to detect pathology from Computed Tomography images.
Progression of disease 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.
Non-fatal vascular events 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 all cause mortality 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.
- Secondary Outcome Measures
Name Time Method Cardiovascular risk factors 15 years Using novel image analysis methods and blood biomarkers, to detect and monitor cardiovascular risk factors and responsiveness to routine clinical care
Genotyping 15 years Using genotyping to predict clinical phenotypes
Hospital admissions for any reason classified using ICD10 15 years Using novel image analysis methods, to predict hospital admissions over a period of 15 years post CT scan
Progression of cardiovascular disease 15 years Using novel image analysis methods, clinical risk factors, and blood biomarkers to predict disease progression measured by CT scans
Validation and refinement of the CaRi Image analysis platform 15 years Validate the prognostic and diagnostic performance of CaRi Image analysis platform against the other study outcomes
Trial Locations
- Locations (37)
Liverpool Heart and Chest Hospital
๐ฌ๐งLiverpool, United Kingdom
NIH National Heart, Lunch, and Blood Institute
๐บ๐ธBethesda, Maryland, United States
Mayo Clinic
๐บ๐ธRochester, Minnesota, United States
Cleveland Clinic Heart and Vascular Institute
๐บ๐ธCleveland, Ohio, United States
Flinders University
๐ฆ๐บAdelaide, Australia
The University of Sydney
๐ฆ๐บSydney, Australia
University Hospitals Leuven
๐ง๐ชLeuven, Belgium
Fudan University
๐จ๐ณShanghai, China
TEDA International Cardiovascular Hospital
๐จ๐ณTianjin, China
Almaviva Sante - Clinique Axium
๐ซ๐ทAix-en-Provence, France
Friedrich-Alexander-Universitat Erlangen-Nurmberg
๐ฉ๐ชErlangen, Germany
University Hospital Ulm
๐ฉ๐ชUlm, Germany
Lefkos Stavros Clinic
๐ฌ๐ทAthens, Greece
MTA-SE Cardiovascular Imaging Research Group
๐ญ๐บBudapest, Hungary
Centro Cardiologico Monzino IRCCS, University of Milan
๐ฎ๐นMilan, Italy
Oita University
๐ฏ๐ตลita, Japan
Seoul National University
๐ฐ๐ทSeoul, Korea, Republic of
Amsterdam Universitair Medische Centra
๐ณ๐ฑAmsterdam, Netherlands
Zuyderland Medical Centre
๐ณ๐ฑSittard, Netherlands
University of Medicine and Pharmacy of Targu Mures
๐ท๐ดTรขrgu-Mureล, Romania
Cleveland Clinic Abu Dhabi
๐ฆ๐ชAbu Dhabi, United Arab Emirates
Royal United Hospitals Bath NHS Foundation Trust
๐ฌ๐งBath, United Kingdom
Sandwell and West Birmingham Hospitals NHS Trust
๐ฌ๐งBirmingham, United Kingdom
University Hospitals Birmingham NHS Trust
๐ฌ๐งBirmingham, United Kingdom
Royal Papworth Hospital NHS Trust
๐ฌ๐งCambridge, United Kingdom
University of Edinburgh, Royal Infirmary
๐ฌ๐งEdinburgh, United Kingdom
Golden Jubilee National Hospital
๐ฌ๐งGlasgow, United Kingdom
NHS Greater Glasgow and Clyde
๐ฌ๐งGlasgow, United Kingdom
Leeds Teaching Hospitals NHS Trust
๐ฌ๐งLeeds, United Kingdom
University Hosptials of Leicester NHS Trust
๐ฌ๐งLeicester, United Kingdom
Barts Health NHS Trust
๐ฌ๐งLondon, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
๐ฌ๐งLondon, United Kingdom
Royal Brompton and Harefield Hospitals
๐ฌ๐งLondon, United Kingdom
University Hospital of Manchester NHS Foundation Trust
๐ฌ๐งManchester, United Kingdom
Milton Keynes University Hospital
๐ฌ๐งMilton Keynes, United Kingdom
Oxford University Hospitals NHS Foundation Trust
๐ฌ๐งOxford, United Kingdom
Heart and Lung Centre, New Cross Hospital
๐ฌ๐งWolverhampton, United Kingdom