The Oxford Risk Factors And Non-Invasive Imaging Study

ClinicalTrials.gov ID

NCT05169333

Lead Sponsor

University of OxfordOTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

250,000Estimated

Last Update Posted

Jul 31, 2026Actual

Start Date

Feb 23, 2016Actual

Primary Completion Date

Feb 2030Estimated

Completion Date

Feb 2030Estimated

Official Title

The Oxford Risk Factors And Non-Invasive Imaging Study

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.

• Cardiovascular Diseases
• Cardiovascular Risk Factors

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Observational Model

Cohort

Time Perspective

Other

Lead Sponsor

University of OxfordOTHER

Collaborators

Caristo Diagnostics LimitedINDUSTRY

Oxford University Hospitals NHS TrustOTHER

British Heart FoundationOTHER

Innovate UKOTHER_GOV

European CommissionOTHER

nickho@bridgingmedicalsilos.com

carlo.dececco@emory.edu

Ehutt@saint-lukes.org

desaim2@ccf.org

Brittany.Weber@UTSouthwestern.edu

gemma.figtree@sydney.edu.au

ruben.debosscher@uzleuven.be

kadoglou.nikolaos@ucy.ac.cy

simowint@rm.dk

alban.redheuil@aphp.fr

meinrad.beer@uniklinik-ulm.de

benetosg@gmail.com

maurovich-horvat.pal@med.semmelweis-univ.hu

filippo.crea@unicatt.it

bkkoo@snu.ac.kr

hclee@kmu.edu.tw

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