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| Name | Class |
|---|---|
| Caristo Diagnostics Limited | INDUSTRY |
| Oxford University Hospitals NHS Trust | OTHER |
| British Heart Foundation | OTHER |
| Innovate UK |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
| 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 |
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Inclusion Criteria:
Inclusion Criteria for study Arms 1, 2 and 3:
Inclusion Criteria for study Arm 4:
• Male or Female, aged 18 -99 years.
Exclusion Criteria:
Exclusion Criteria for Study Arms 1, 2 and 3:
Exclusion Criteria for Study Arm 4:
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Patients will be recruited from secondary and tertiary NHS care providers in the UK and from international sites.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kenneth Chan | Contact | kenneth.chan@cardiov.ox.ac.uk | ||
| Charalambos Antoniades | Contact | charalambos.antoniades@cardiov.ox.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Antoniades | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIH National Heart, Lunch, and Blood Institute | Recruiting | Bethesda | Maryland | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39023142 | Derived | Westwood M, Armstrong N, Krijkamp E, Perry M, Noake C, Tsiachristas A, Corro-Ramos I. A cloud-based medical device for predicting cardiac risk in suspected coronary artery disease: a rapid review and conceptual economic model. Health Technol Assess. 2024 Jul;28(31):1-105. doi: 10.3310/WYGC4096. |
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| OTHER_GOV |
| European Commission | OTHER |
| National Consortium of Intelligent Medical Imaging | UNKNOWN |
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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 |
| Mayo Clinic |
| Not yet recruiting |
| Rochester |
| Minnesota |
| United States |
| Cleveland Clinic Heart and Vascular Institute | Recruiting | Cleveland | Ohio | United States |
| Flinders University | Not yet recruiting | Adelaide | Australia |
| The University of Sydney | Not yet recruiting | Sydney | Australia |
| University Hospitals Leuven | Not yet recruiting | Leuven | Belgium |
| Fudan University | Not yet recruiting | Shanghai | China |
| TEDA International Cardiovascular Hospital | Not yet recruiting | Tianjin | China |
| Almaviva Sante - Clinique Axium | Not yet recruiting | Aix-en-Provence | France |
| Friedrich-Alexander-Universitat Erlangen-Nurmberg | Recruiting | Erlangen | Germany |
| University Hospital Ulm | Not yet recruiting | Ulm | Germany |
| Lefkos Stavros Clinic | Recruiting | Athens | Greece |
| MTA-SE Cardiovascular Imaging Research Group | Recruiting | Budapest | Hungary |
| Centro Cardiologico Monzino IRCCS, University of Milan | Recruiting | Milan | Italy |
| Oita University | Recruiting | Ōita | Japan |
| Amsterdam Universitair Medische Centra | Not yet recruiting | Amsterdam | Netherlands |
| Zuyderland Medical Centre | Not yet recruiting | Sittard | Netherlands |
| University of Medicine and Pharmacy of Targu Mures | Recruiting | Târgu Mureş | Romania |
| Seoul National University | Recruiting | Seoul | South Korea |
| Cleveland Clinic Abu Dhabi | Not yet recruiting | Abu Dhabi | United Arab Emirates |
| Royal United Hospitals Bath NHS Foundation Trust | Recruiting | Bath | United Kingdom |
| Sandwell and West Birmingham Hospitals NHS Trust | Recruiting | Birmingham | United Kingdom |
| University Hospitals Birmingham NHS Trust | Not yet recruiting | Birmingham | United Kingdom |
| Royal Papworth Hospital NHS Trust | Recruiting | Cambridge | United Kingdom |
| University of Edinburgh, Royal Infirmary | Not yet recruiting | Edinburgh | United Kingdom |
| Golden Jubilee National Hospital | Not yet recruiting | Glasgow | United Kingdom |
| NHS Greater Glasgow and Clyde | Not yet recruiting | Glasgow | United Kingdom |
| Leeds Teaching Hospitals NHS Trust | Recruiting | Leeds | United Kingdom |
| University Hosptials of Leicester NHS Trust | Recruiting | Leicester | United Kingdom |
| Liverpool Heart and Chest Hospital | Not yet recruiting | Liverpool | United Kingdom |
| Barts Health NHS Trust | Recruiting | London | United Kingdom |
| Guy's and St Thomas' NHS Foundation Trust | Recruiting | London | United Kingdom |
| Royal Brompton and Harefield Hospitals | Recruiting | London | United Kingdom |
| University Hospital of Manchester NHS Foundation Trust | Not yet recruiting | Manchester | United Kingdom |
| Milton Keynes University Hospital | Recruiting | Milton Keynes | United Kingdom |
| Oxford University Hospitals NHS Foundation Trust | Recruiting | Oxford | United Kingdom |
| Heart and Lung Centre, New Cross Hospital | Recruiting | Wolverhampton | United Kingdom |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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