The Oxford Risk Factors And Non-Invasive Imaging Study (ORFAN)

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Cardiovascular Risk Factors

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.

• Study Type: Observational
• Enrollment (Anticipated): 250000

Contacts and Locations

• Study Contact: Name: Kingham; Email: orfan@cardiov.ox.ac.uk

Study Locations

• Australia
  • Adelaide, Australia
    • Not yet recruiting
    • Flinders University
  • Sydney, Australia
    • Not yet recruiting
    • The University of Sydney
• Belgium
  • Leuven, Belgium
    • Not yet recruiting
    • University Hospitals Leuven
• China
  • Shanghai, China
    • Not yet recruiting
    • Fudan University
  • Tianjin, China
    • Not yet recruiting
    • TEDA International Cardiovascular Hospital
• France
  • Aix-en-Provence, France
    • Not yet recruiting
    • Almaviva Sante - Clinique Axium
• Germany
  • Erlangen, Germany
    • Recruiting
    • Friedrich-Alexander-Universitat Erlangen-Nurmberg
  • Ulm, Germany
    • Not yet recruiting
    • University Hospital Ulm
• Greece
  • Athens, Greece
    • Recruiting
    • Lefkos Stavros Clinic
• Hungary
  • Budapest, Hungary
    • Recruiting
    • MTA-SE Cardiovascular Imaging Research Group
• Italy
  • Milan, Italy
    • Recruiting
    • Centro Cardiologico Monzino IRCCS, University of Milan
• Japan
  • Ōita, Japan
    • Recruiting
    • Oita University
• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University
• Netherlands
  • Amsterdam, Netherlands
    • Not yet recruiting
    • Amsterdam Universitair Medische centra
  • Sittard, Netherlands
    • Not yet recruiting
    • Zuyderland Medical Centre
• Romania
  • Târgu-Mureş, Romania
    • Recruiting
    • University of Medicine and Pharmacy of Targu Mures
• United Arab Emirates
  • Abu Dhabi, United Arab Emirates
    • Not yet recruiting
    • Cleveland Clinic Abu Dhabi
• United Kingdom
  • Bath, United Kingdom
    • Recruiting
    • Royal United Hospitals Bath NHS Foundation Trust
  • Birmingham, United Kingdom
    • Not yet recruiting
    • Sandwell and West Birmingham Hospitals NHS Trust
  • Birmingham, United Kingdom
    • Not yet recruiting
    • University Hospitals Birmingham NHS Trust
  • Cambridge, United Kingdom
    • Recruiting
    • Royal Papworth Hospital NHS Trust
  • Edinburgh, United Kingdom
    • Not yet recruiting
    • University of Edinburgh, Royal Infirmary
  • Glasgow, United Kingdom
    • Not yet recruiting
    • NHS Greater Glasgow and Clyde
  • Glasgow, United Kingdom
    • Not yet recruiting
    • Golden Jubilee National Hospital
  • Leeds, United Kingdom
    • Not yet recruiting
    • Leeds Teaching Hospitals NHS Trust
  • Leicester, United Kingdom
    • Recruiting
    • University Hosptials of Leicester NHS Trust
  • London, United Kingdom
    • 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
  • Manchester, United Kingdom
    • Not yet recruiting
    • University Hospital of Manchester NHS Foundation Trust
  • Milton Keynes, United Kingdom
    • Recruiting
    • Milton Keynes University Hospital
  • Oxford, United Kingdom
    • Recruiting
    • Oxford University Hospitals NHS Foundation Trust
  • Wolverhampton, United Kingdom
    • Not yet recruiting
    • Heart and Lung Centre, New Cross Hospital
• United States
  • Maryland
    • Bethesda, Maryland, United States
      • Recruiting
      • NIH National Heart, Lunch, and Blood Institute
  • Minnesota
    • Rochester, Minnesota, United States
      • Not yet recruiting
      • Mayo Clinic
  • Ohio
    • Cleveland, Ohio, United States
      • Recruiting
      • Cleveland Clinic Heart and Vascular Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular risk factors	Using novel image analysis methods and blood biomarkers, to detect and monitor cardiovascular risk factors and responsiveness to routine clinical care	15 years
Hospital admissions for any reason classified using ICD10	Using novel image analysis methods, to predict hospital admissions over a period of 15 years post CT scan	15 years
Genotyping	Using genotyping to predict clinical phenotypes	15 years
Progression of cardiovascular disease	Using novel image analysis methods, clinical risk factors, and blood biomarkers to predict disease progression measured by CT scans	15 years
Validation and refinement of the CaRi Image analysis platform	Validate the prognostic and diagnostic performance of CaRi Image analysis platform against the other study outcomes	15 years

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: British Heart Foundation; European Commission; Oxford University Hospitals NHS Trust; Innovate UK; National Consortium of Intelligent Medical Imaging; Caristo Diagnostics Limited
• Investigators: Principal Investigator: Antoniades, University of Oxford

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2016
• Primary Completion (Anticipated): February 1, 2030
• Study Completion (Anticipated): February 1, 2030

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: December 22, 2021
• First Posted (Actual): December 23, 2021

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: The ORFAN Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No