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NCT05169333

The Oxford Risk Factors And Non-Invasive Imaging Study

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-23

Study Completion Date

2030-02-28

Brief Summary

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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

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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.

Conditions

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Cardiovascular Diseases Cardiovascular Risk Factors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Group 1

Participants attending cardiology department, hypertension or outpatient clinics.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antoniades

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

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Kenneth Chan

Role: CONTACT

Email: [email protected]

Charalambos Antoniades

Role: CONTACT

Email: [email protected]

References

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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.

Reference Type DERIVED

PMID: 39023142 (View on PubMed)

Other Identifiers

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The ORFAN Study

Identifier Type: -

Identifier Source: org_study_id

The Oxford Risk Factors And Non-Invasive Imaging Study

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Group 1

Group 2

Group 3

Group 4

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Caristo Diagnostics Limited

Oxford University Hospitals NHS Trust

British Heart Foundation

Innovate UK

European Commission

National Consortium of Intelligent Medical Imaging

University of Oxford

Responsible Party

Principal Investigators

Antoniades

Locations

NIH National Heart, Lunch, and Blood Institute

Mayo Clinic

Cleveland Clinic Heart and Vascular Institute

Flinders University

The University of Sydney

University Hospitals Leuven

Fudan University

TEDA International Cardiovascular Hospital

Almaviva Sante - Clinique Axium

Friedrich-Alexander-Universitat Erlangen-Nurmberg

University Hospital Ulm

Lefkos Stavros Clinic

MTA-SE Cardiovascular Imaging Research Group

Centro Cardiologico Monzino IRCCS, University of Milan

Oita University

Amsterdam Universitair Medische Centra

Zuyderland Medical Centre

University of Medicine and Pharmacy of Targu Mures

Seoul National University

Cleveland Clinic Abu Dhabi

Royal United Hospitals Bath NHS Foundation Trust

Sandwell and West Birmingham Hospitals NHS Trust

University Hospitals Birmingham NHS Trust

Royal Papworth Hospital NHS Trust

University of Edinburgh, Royal Infirmary

Golden Jubilee National Hospital

NHS Greater Glasgow and Clyde

Leeds Teaching Hospitals NHS Trust

University Hosptials of Leicester NHS Trust

Liverpool Heart and Chest Hospital

Barts Health NHS Trust

Guy's and St Thomas' NHS Foundation Trust

Royal Brompton and Harefield Hospitals

University Hospital of Manchester NHS Foundation Trust

Milton Keynes University Hospital

Oxford University Hospitals NHS Foundation Trust

Heart and Lung Centre, New Cross Hospital

Countries

Central Contacts

Kenneth Chan

Charalambos Antoniades

References

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.

Other Identifiers

The ORFAN Study