Clincosm LogoSign in Get a demo

ORFAN: The Oxford Risk Factors And Non-Invasive Imaging Study

Sponsor
University of Oxford (Other)
Overall Status
Recruiting
CT.gov ID
NCT05169333
Collaborator
Caristo Diagnostics (Other), National Consortium of Intelligent Medical Imaging (Other), Oxford University Hospitals NHS Trust (Other), British Heart Foundation (Other), Innovate UK (Other), European Commission (Other)
250,000
Enrollment
36
Locations
167.3
Anticipated Duration (Months)
6944.4
Patients Per Site
41.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    250000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    The Oxford Risk Factors And Non-Invasive Imaging Study
    Actual Study Start Date :
    Feb 23, 2016
    Anticipated Primary Completion Date :
    Feb 1, 2030
    Anticipated Study Completion Date :
    Feb 1, 2030

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Cardiac and all cause mortality [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 [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 [15 years]

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

    4. Progression of disease [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 Outcome Measures

    1. Cardiovascular risk factors [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 [15 years]

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

    3. Genotyping [15 years]

      Using genotyping to predict clinical phenotypes

    4. Progression of cardiovascular disease [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 [15 years]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NIH National Heart, Lunch, and Blood Institute Bethesda Maryland United States
    2 Mayo Clinic Rochester Minnesota United States
    3 Cleveland Clinic Heart and Vascular Institute Cleveland Ohio United States
    4 Flinders University Adelaide Australia
    5 The University of Sydney Sydney Australia
    6 University Hospitals Leuven Leuven Belgium
    7 Fudan University Shanghai China
    8 TEDA International Cardiovascular Hospital Tianjin China
    9 Almaviva Sante - Clinique Axium Aix-en-Provence France
    10 Friedrich-Alexander-Universitat Erlangen-Nurmberg Erlangen Germany
    11 University Hospital Ulm Ulm Germany
    12 Lefkos Stavros Clinic Athens Greece
    13 MTA-SE Cardiovascular Imaging Research Group Budapest Hungary
    14 Centro Cardiologico Monzino IRCCS, University of Milan Milan Italy
    15 Oita University Ōita Japan
    16 Seoul National University Seoul Korea, Republic of
    17 Amsterdam Universitair Medische Centra Amsterdam Netherlands
    18 Zuyderland Medical Centre Sittard Netherlands
    19 University of Medicine and Pharmacy of Targu Mures Târgu-Mureş Romania
    20 Cleveland Clinic Abu Dhabi Abu Dhabi United Arab Emirates
    21 Royal United Hospitals Bath NHS Foundation Trust Bath United Kingdom
    22 Sandwell and West Birmingham Hospitals NHS Trust Birmingham United Kingdom
    23 University Hospitals Birmingham NHS Trust Birmingham United Kingdom
    24 Royal Papworth Hospital NHS Trust Cambridge United Kingdom
    25 University of Edinburgh, Royal Infirmary Edinburgh United Kingdom
    26 Golden Jubilee National Hospital Glasgow United Kingdom
    27 NHS Greater Glasgow and Clyde Glasgow United Kingdom
    28 Leeds Teaching Hospitals NHS Trust Leeds United Kingdom
    29 University Hosptials of Leicester NHS Trust Leicester United Kingdom
    30 Barts Health NHS Trust London United Kingdom
    31 Guy's and St Thomas' NHS Foundation Trust London United Kingdom
    32 Royal Brompton and Harefield Hospitals London United Kingdom
    33 University Hospital of Manchester NHS Foundation Trust Manchester United Kingdom
    34 Milton Keynes University Hospital Milton Keynes United Kingdom
    35 Oxford University Hospitals NHS Foundation Trust Oxford United Kingdom
    36 Heart and Lung Centre, New Cross Hospital Wolverhampton United Kingdom

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Antoniades, University of Oxford

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Oxford
    ClinicalTrials.gov Identifier:
    NCT05169333
    Other Study ID Numbers:
    • The ORFAN Study
    First Posted:
    Dec 23, 2021
    Last Update Posted:
    Dec 23, 2021
    Last Verified:
    Dec 1, 2021
    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
    Additional relevant MeSH terms:
    Cardiovascular Diseases

    Study Results

    No Results Posted as of Dec 23, 2021