The Oxford Risk Factors And Non-Invasive Imaging Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Oxford Risk Factors And Non-Invasive Imaging Study

Conditions
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Cardiovascular Diseases, Cardiovascular Risk Factors

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Participants attending cardiology department, hypertension or outpatient clinics. | |
| Group 2<br>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<br>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<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |