The Oxford Risk Factors And Non-Invasive Imaging Study

NCT05169333 | Recruiting

• 1 other identifier: The ORFAN Study
• Study Type: observational
• Target: 250,000
• Locations: 14 countries
• Sites: 45

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

Study Sites (45)

Valleywise Health

Phoenix, Arizona, United States

RECRUITING

Yale University, School of Medicine

New Haven, Connecticut, United States

RECRUITING

Bridging Medical Silos

Tampa, Florida, United States

RECRUITING

Emory University

Atlanta, Georgia, United States

RECRUITING

Midwest Heart & Vascular Specialists LLC

Kansas City, Kansas, United States

RECRUITING

St Luke's Hospital

Kansas City, Kansas, United States

RECRUITING

NIH National Heart, Lunch, and Blood Institute

Bethesda, Maryland, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, United States

RECRUITING

UT Southwestern Medical Center

Dallas, Texas, United States

RECRUITING

Brooke Army Medical Center (BAMC)

San Antonio, Texas, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, United States

RECRUITING

The University of Sydney

Sydney, Australia

NOT YET RECRUITING

University Hospitals Leuven

Leuven, Belgium

NOT YET RECRUITING

Nicosia Polyclinic

Nicosia, Cyprus

RECRUITING

GØdstrup Regional hospital

Aarhus, Denmark

RECRUITING

Assistance Publique - Hôpitaux de Paris

Paris, France

RECRUITING

Friedrich-Alexander-Universitat Erlangen-Nurmberg

Erlangen, Germany

RECRUITING

University Hospital Ulm

Ulm, Germany

NOT YET RECRUITING

Lefkos Stavros Clinic

Athens, Greece

RECRUITING

National and Kapodistrian University of Athens - Hippokration Hospital

Athens, Greece

RECRUITING

Semmelweis University

Budapest, Hungary

RECRUITING

Centro Cardiologico Monzino IRCCS, University of Milan

Milan, Italy

RECRUITING

Isola Tiberina-Gemelli Isola Hospital

Roma, Italy

RECRUITING

University of Medicine and Pharmacy of Targu Mures

Târgu Mureş, Romania

RECRUITING

Seoul National University

Seoul, South Korea

RECRUITING

Taiwan Kaohsiung Medical University

Kaohsiung City, Taiwan

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

The Newcastle Hospitals NHS Foundation Trust

Newcastle upon Tyne, 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

• Charalambos Antoniades, Prof

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth Chan, Dr

CONTACT

kenneth.chan@cardiov.ox.ac.uk

Ahmad Abdullrahman, Dr

CONTACT

orfan@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: July 31, 2026

Record last verified: 2024-12

Locations

AU (1); GR (2); FR (1); GB (18); RO (1); US (12); IT (2); HU (1); BE (1); DE (2); DK (1); TW (1); CY (1); KR (1)