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NCT Number: NCT05169333

The Oxford Risk Factors And Non-Invasive Imaging Study

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.

Recruiting

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Flinders University, Adelaide, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Cardiac and all cause mortality

    Time frame: 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.

  2. Non-fatal vascular events

    Time frame: 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.

  3. Cardiac and non-cardiac findings by Computed Tomography

    Time frame: 15 years

    Using novel image analysis methods, clinical risk factors, and blood biomarkers to detect pathology from Computed Tomography images.

  4. Progression of disease

    Time frame: 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.

Secondary outcomes

  1. Cardiovascular risk factors

    Time frame: 15 years

    Using novel image analysis methods and blood biomarkers, to detect and monitor cardiovascular risk factors and responsiveness to routine clinical care

  2. Hospital admissions for any reason classified using ICD10

    Time frame: 15 years

    Using novel image analysis methods, to predict hospital admissions over a period of 15 years post CT scan

  3. Genotyping

    Time frame: 15 years

    Using genotyping to predict clinical phenotypes

  4. Progression of cardiovascular disease

    Time frame: 15 years

    Using novel image analysis methods, clinical risk factors, and blood biomarkers to predict disease progression measured by CT scans

  5. Validation and refinement of the CaRi Image analysis platform

    Time frame: 15 years

    Validate the prognostic and diagnostic performance of CaRi Image analysis platform against the other study outcomes

Study contacts

Contact information is provided by the study sponsor or research team.

Charalambos Antoniades

CONTACT

[email protected]

Kenneth Chan

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

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

Registry information

Acronym: ORFAN

Important dates

Study start
2016
Primary completion
2030
Study completion
2030
First posted
Dec 23, 2021
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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