The Healthcare Evaluation of Absolute Risk Testing Study (HEART)

Genomics PLC

Status: Completed

Conditions: Cardiovascular Diseases

Treatments: Device: CVD Integrated Risk Test

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05294419

GEN2020-02

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 862 patients

Sex: All

Ages: 45 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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862 participants in 1 patient group

Per participant - cardiovascular integrated risk score (CVD-IRT)

Other group

Description:

The CVD IRT device will generate a result based on the polygenic risk score derived from participant genomic and phenotypic information

Treatment:

Device: CVD Integrated Risk Test