Cardiovascular Diseases, Cardiovascular Risk Factors
Conditions
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.
Interventions
None listed
Sponsors
University of Oxford
Caristo Diagnostics Limited
Oxford University Hospitals NHS Trust
British Heart Foundation
Innovate UK
European Commission
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Genotyping | 15 years | Using genotyping to predict clinical phenotypes |
| 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 |
| 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 |
Countries
Australia, Belgium, Cyprus, Denmark, France, Germany, Greece, Hungary, Italy, Romania, South Korea, Taiwan, United Kingdom, United States
Contacts
CONTACTKenneth Chan, Dr
CONTACTAhmad Abdullrahman, Dr
PRINCIPAL_INVESTIGATORCharalambos Antoniades, Prof
University of Oxford
Outcome results
None listed