The Healthcare Evaluation of Absolute Risk Testing Study

Study Overview
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Brief Summary
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The aim of this study is to demonstrate the integration and use of cardiovascular disease (CVD) integrated risk tool (IRT) in an environment as close to real-world as possible. This study will recruit participants of both biological sexes and any ancestry or background who require and are eligible for a CVD risk assessment as part of the NHS Health Check. Those aged 45-64 years are most likely to benefit from CVD IRT and will be included in the study, as they are more likely to be asymptomatic but also derive most benefit from preventative measures. The study will be conducted in GP surgeries as the CVD IRT will have its greatest impact if incorporated into primary care practice for early identification of patients at highest risk. This study is a device performance evaluation.

Detailed Description
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The aim of this study is to demonstrate the integration and use of a cardiovascular disease (CVD) integrated risk tool (IRT) in an environment as close to real-world as possible. In association with the routine healthchecks for CVD, the QRISK score will be integrated with the individuals polygenic risk score (from a blood sample) to produce the CVD IRT score, this score estimates the risk of CVD in the following 10years. This study will recruit participants of both biological sexes and any ancestry or background who require and are eligible for a CVD risk assessment as part of the NHS Health Check. Those aged 45-64 years are most likely to benefit from CVD IRT and will be included in the study, as they are more likely to be asymptomatic but also derive most benefit from preventative measures. The study will be conducted in GP surgeries as the CVD IRT will have its greatest impact if incorporated into primary care practice for early identification of patients at highest risk. This study is a device performance evaluation. 1000 participants are expected to be enrolled. Of this, it is expected that 200 surveys will be completed and from those surveyed 20-30 interviewed. This would be considered an adequate determination of feasibility.

Official Title
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The Healthcare Evaluation of Absolute Risk Testing Study: A Multi-centre, Single Arm, Pragmatic Study in Primary Care Setting

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Device: CVD Integrated Risk Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able and willing to provide written informed consent and to comply with the study protocol Either male or female (biological sex) Aged 45-64 years (inclusive) Any ancestry or background Eligible for NHS Health Check using QRISK®2 assessment Exclusion Criteria: Those excluded from NHS Health Checks; Currently prescribed and taking HMG-CoA reductase inhibitors (lipid-lowering preventive treatments or statins) for any indication.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: cardiovascular integrated risk score (CVD-IRT)<br>The CVD IRT device will generate a result based on the polygenic risk score derived from participant genomic information | Device: CVD Integrated Risk Test<br>* CVD IRT (IVD regulations with a software device)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate that an IRT (combining genetic and non-genetic risk factors) for CVD can be incorporated into routine primary care. | Descriptive analysis of Participant surveys completed using Likert scale | Participant surveys completed 12-16 weeks after enrolment | 
| To demonstrate that an IRT (combining genetic and non-genetic risk factors) for CVD can be incorporated into routine primary care. | Descriptive analysis of Healthcare professional surveys completed using Likert scale | Clinician surveys at the point of reported CVD-IRT (9-12 weeks after participant enrollment ) | 
| To demonstrate that an IRT (combining genetic and non-genetic risk factors) for CVD can be incorporated into routine primary care. | Descriptive analysis of report rate | Up to 12 weeks after participant enrolment and sample collection at visit 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To explore and assess the impact of the CVD IRT on clinical decision-making. | Descriptive analysis of Clinician surveys completed at the time of CVD-IRT report to indicate the potential influence the CVD-IRT score would make to the current clinical treatment practice. | Data collected within 2 weeks of CVD-IRT report (9-12 weeks after participant enrolment) | 
| To assess the magnitude of the change in risk score between QRISK®2 and CVD IRT | Analysis of the difference between the QRISK and CVD -IRT scores in the cohort for participants who have increased or decreased risk due to the introduction of a polygenic risk score and present this data | CVD IRT report expected 9-12 weeks after visit 1. Analysis will be performed after all samples are analysed by laboratory methods | 
| To explore and assess to what extent HCPs and PCCs perceive the CVD IRT as operationally efficient and enhancing the service that they provide | Descriptive analysis of Clinician and PCC (primary care commissioning groups) interviews completed at the end of participant participation | Data collected within 2 months of last participant CVD-IRT report | 
| To explore and assess to what extent HCPs and PCCs perceive the CVD IRT as clinically relevant | Descriptive analysis of Clinician and PCC (primary care commissioning groups) as interviews completed at the end of participant participation | Data collected within 2 months of last participant CVD-IRT report | 
| To explore and assess to what extent participants perceive the information received through the CVD IRT as informative for health and wellness | Descriptive analysis of Participant interviews completed at the end of participant participation | Data collected within 2 weeks of CVD-IRT report and interview within 2 months of CVD-IRT report | 
| To explore and assess the impact of the CVD IRT on patient engagement | Descriptive analysis of Participant interviews completed at the end of participant participation | Data collected within 2 weeks of report and interview within 2 months of CVD-IRT report | 
| To identify and explore effective ways to communicate risk and genetics information about CVD IRT to patients, HCP and PCCs | Descriptive analysis of Participant, HCP and PCC interviews completed at the end of participant participation | Data collected within 2 weeks of report and interview within 2 months of CVD-IRT report | 
| Comparison between saliva and blood | Analysis of saliva as compared to blood CVD-IRT results as analysed by laboratory methods | Samples collected at visit 1 will be analysed through study completion, up to 1 year | 
| Safety of CVD-IRT | Reporting of AE and device related deficiencies | Participant visit 1 to last participant interview or withdrawal |