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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05169333




Registration number
NCT05169333
Ethics application status
Date submitted
12/10/2021
Date registered
23/12/2021
Date last updated
11/05/2023

Titles & IDs
Public title
The Oxford Risk Factors And Non-Invasive Imaging Study
Scientific title
The Oxford Risk Factors And Non-Invasive Imaging Study
Secondary ID [1] 0 0
The ORFAN Study
Universal Trial Number (UTN)
Trial acronym
ORFAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Diseases 0 0
Cardiovascular Risk Factors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cardiac and all cause mortality
Timepoint [1] 0 0
15 years
Primary outcome [2] 0 0
Non-fatal vascular events
Timepoint [2] 0 0
15 years
Primary outcome [3] 0 0
Cardiac and non-cardiac findings by Computed Tomography
Timepoint [3] 0 0
15 years
Primary outcome [4] 0 0
Progression of disease
Timepoint [4] 0 0
15 years
Secondary outcome [1] 0 0
Cardiovascular risk factors
Timepoint [1] 0 0
15 years
Secondary outcome [2] 0 0
Hospital admissions for any reason classified using ICD10
Timepoint [2] 0 0
15 years
Secondary outcome [3] 0 0
Genotyping
Timepoint [3] 0 0
15 years
Secondary outcome [4] 0 0
Progression of cardiovascular disease
Timepoint [4] 0 0
15 years
Secondary outcome [5] 0 0
Validation and refinement of the CaRi Image analysis platform
Timepoint [5] 0 0
15 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/02/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2030
Actual
Sample size
Target
250000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders University - Adelaide
Recruitment hospital [2] 0 0
The University of Sydney - Sydney
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Maryland
Country [2] 0 0
United States of America
State/province [2] 0 0
Minnesota
Country [3] 0 0
United States of America
State/province [3] 0 0
Ohio
Country [4] 0 0
Belgium
State/province [4] 0 0
Leuven
Country [5] 0 0
China
State/province [5] 0 0
Shanghai
Country [6] 0 0
China
State/province [6] 0 0
Tianjin
Country [7] 0 0
France
State/province [7] 0 0
Aix-en-Provence
Country [8] 0 0
Germany
State/province [8] 0 0
Erlangen
Country [9] 0 0
Germany
State/province [9] 0 0
Ulm
Country [10] 0 0
Greece
State/province [10] 0 0
Athens
Country [11] 0 0
Hungary
State/province [11] 0 0
Budapest
Country [12] 0 0
Italy
State/province [12] 0 0
Milan
Country [13] 0 0
Japan
State/province [13] 0 0
Oita
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Seoul
Country [15] 0 0
Netherlands
State/province [15] 0 0
Amsterdam
Country [16] 0 0
Netherlands
State/province [16] 0 0
Sittard
Country [17] 0 0
Romania
State/province [17] 0 0
Târgu-Mures
Country [18] 0 0
United Arab Emirates
State/province [18] 0 0
Abu Dhabi
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Bath
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Birmingham
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Cambridge
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Edinburgh
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Glasgow
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Leeds
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Leicester
Country [26] 0 0
United Kingdom
State/province [26] 0 0
London
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Manchester
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Milton Keynes
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Oxford
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Other
Name
University of Oxford
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Caristo Diagnostics Limited
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
National Consortium of Intelligent Medical Imaging
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Oxford University Hospitals NHS Trust
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
British Heart Foundation
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Innovate UK
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
European Commission
Address [6] 0 0
Country [6] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05169333
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Antoniades
Address 0 0
University of Oxford
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kingham
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
orfan@cardiov.ox.ac.uk
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05169333