The Oxford Risk Factors And Non-Invasive Imaging Study

NCT05169333 | Recruiting

• 1 other identifier: The ORFAN Study
• Study Type: observational
• Target: 250,000
• Locations: 15 countries
• Sites: 37

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.

Conditions

Cardiovascular Diseases; Cardiovascular Risk Factors

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  15 years

Secondary Outcomes (5)

• Cardiovascular risk factors

  15 years

• Hospital admissions for any reason classified using ICD10

  15 years

• Genotyping

  15 years

• Progression of cardiovascular disease

  15 years

• Validation and refinement of the CaRi Image analysis platform

  15 years

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead
• Caristo Diagnostics Limited: collaborator
• Oxford University Hospitals NHS Trust: collaborator
• British Heart Foundation: collaborator
• Innovate UK: collaborator
• European Commission: collaborator
• National Consortium of Intelligent Medical Imaging: collaborator

Study Sites (37)

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

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Antoniades

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth Chan

CONTACT

kenneth.chan@cardiov.ox.ac.uk

Charalambos Antoniades

CONTACT

charalambos.antoniades@cardiov.ox.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 15 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: December 23, 2021
• Study Start: February 23, 2016
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2030
• Last Updated: December 11, 2024

Record last verified: 2024-12

Locations

AU (2); CN (2); GR (1); FR (1); GB (17); RO (1); US (3); IT (1); AE (1); KR (1); HU (1); BE (1); JP (1); NL (2); DE (2)