The Oxford Risk Factors And Non-Invasive Imaging Study

Cardiovascular Diseases Clinical Trial

— ORFAN  

Official title:

The Oxford Risk Factors And Non-Invasive Imaging Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05169333
• Other study ID #: The ORFAN Study
• Status: Recruiting
• Start date: February 23, 2016
• Est. completion date: February 2030

Study information

• Verified date: May 2023
• Source: University of Oxford
• Contact: Kingham
• Email: orfan[@]cardiov.ox.ac.uk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250000
• Est. completion date: February 2030
• Est. primary completion date: February 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cardiovascular Risk Factors

Locations

Country	Name	City	State
Australia	Flinders University	Adelaide
Australia	The University of Sydney	Sydney
Belgium	University Hospitals Leuven	Leuven
China	Fudan University	Shanghai
China	TEDA International Cardiovascular Hospital	Tianjin
France	Almaviva Sante - Clinique Axium	Aix-en-Provence
Germany	Friedrich-Alexander-Universitat Erlangen-Nurmberg	Erlangen
Germany	University Hospital Ulm	Ulm
Greece	Lefkos Stavros Clinic	Athens
Hungary	MTA-SE Cardiovascular Imaging Research Group	Budapest
Italy	Centro Cardiologico Monzino IRCCS, University of Milan	Milan
Japan	Oita University	Oita
Korea, Republic of	Seoul National University	Seoul
Netherlands	Amsterdam Universitair Medische Centra	Amsterdam
Netherlands	Zuyderland Medical Centre	Sittard
Romania	University of Medicine and Pharmacy of Targu Mures	Târgu-Mures
United Arab Emirates	Cleveland Clinic Abu Dhabi	Abu Dhabi
United Kingdom	Royal United Hospitals Bath NHS Foundation Trust	Bath
United Kingdom	Sandwell and West Birmingham Hospitals NHS Trust	Birmingham
United Kingdom	University Hospitals Birmingham NHS Trust	Birmingham
United Kingdom	Royal Papworth Hospital NHS Trust	Cambridge
United Kingdom	University of Edinburgh, Royal Infirmary	Edinburgh
United Kingdom	Golden Jubilee National Hospital	Glasgow
United Kingdom	NHS Greater Glasgow and Clyde	Glasgow
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds
United Kingdom	University Hosptials of Leicester NHS Trust	Leicester
United Kingdom	Barts Health NHS Trust	London
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
United Kingdom	Royal Brompton and Harefield Hospitals	London
United Kingdom	University Hospital of Manchester NHS Foundation Trust	Manchester
United Kingdom	Milton Keynes University Hospital	Milton Keynes
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford
United Kingdom	Heart and Lung Centre, New Cross Hospital	Wolverhampton
United States	NIH National Heart, Lunch, and Blood Institute	Bethesda	Maryland
United States	Cleveland Clinic Heart and Vascular Institute	Cleveland	Ohio
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (7)

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

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  China,  France,  Germany,  Greece,  Hungary,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Romania,  United Arab Emirates,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Genotyping	Using genotyping to predict clinical phenotypes	15 years
Secondary	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
Secondary	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