Clinical trial NCT05169333: The Oxford Risk Factors And Non-Invasive Imaging Study
Official title: The Oxford Risk Factors And Non-Invasive Imaging Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Cardiovascular Risk Factors
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Caristo Diagnostics Limited
name: Oxford University Hospitals NHS Trust
name: British Heart Foundation
name: Innovate UK
name: European Commission
name: National Consortium of Intelligent Medical Imaging
First posted: 2021-12-23
Enrollment: 250000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from secondary and tertiary NHS care providers in the UK and from international sites.

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.

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

Primary outcomes:
measure: Cardiac and all cause mortality
timeFrame: 15 years
measure: Non-fatal vascular events
timeFrame: 15 years
measure: Cardiac and non-cardiac findings by Computed Tomography
timeFrame: 15 years
measure: Progression of disease
timeFrame: 15 years
Secondary outcomes:
measure: Cardiovascular risk factors
timeFrame: 15 years
measure: Hospital admissions for any reason classified using ICD10
timeFrame: 15 years
measure: Genotyping
timeFrame: 15 years
measure: Progression of cardiovascular disease
timeFrame: 15 years
measure: Validation and refinement of the CaRi Image analysis platform
timeFrame: 15 years
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: NIH National Heart, Lunch, and Blood Institute
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Cleveland
country: United States
facility: Cleveland Clinic Heart and Vascular Institute
state: Ohio
city: Adelaide
country: Australia
facility: Flinders University
city: Sydney
country: Australia
facility: The University of Sydney
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Shanghai
country: China
facility: Fudan University
city: Tianjin
country: China
facility: TEDA International Cardiovascular Hospital
city: Aix-en-Provence
country: France
facility: Almaviva Sante - Clinique Axium
city: Erlangen
country: Germany
facility: Friedrich-Alexander-Universitat Erlangen-Nurmberg
city: Ulm
country: Germany
facility: University Hospital Ulm
city: Athens
country: Greece
facility: Lefkos Stavros Clinic
city: Budapest
country: Hungary
facility: MTA-SE Cardiovascular Imaging Research Group
city: Milan
country: Italy
facility: Centro Cardiologico Monzino IRCCS, University of Milan
city: Ōita
country: Japan
facility: Oita University
city: Seoul
country: Korea, Republic of
facility: Seoul National University
city: Amsterdam
country: Netherlands
facility: Amsterdam Universitair Medische Centra
city: Sittard
country: Netherlands
facility: Zuyderland Medical Centre
city: Târgu-Mureş
country: Romania
facility: University of Medicine and Pharmacy of Targu Mures
city: Abu Dhabi
country: United Arab Emirates
facility: Cleveland Clinic Abu Dhabi
city: Bath
country: United Kingdom
facility: Royal United Hospitals Bath NHS Foundation Trust
city: Birmingham
country: United Kingdom
facility: Sandwell and West Birmingham Hospitals NHS Trust
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Trust
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital NHS Trust
city: Edinburgh
country: United Kingdom
facility: University of Edinburgh, Royal Infirmary
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
city: Leicester
country: United Kingdom
facility: University Hosptials of Leicester NHS Trust
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal Brompton and Harefield Hospitals
city: Manchester
country: United Kingdom
facility: University Hospital of Manchester NHS Foundation Trust
city: Milton Keynes
country: United Kingdom
facility: Milton Keynes University Hospital
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
city: Wolverhampton
country: United Kingdom
facility: Heart and Lung Centre, New Cross Hospital
Study officials:
affiliation: University of Oxford
name: Antoniades
role: PRINCIPAL_INVESTIGATOR
References: