The Healthcare Evaluation of Absolute Risk Testing Study

NCT ID: NCT05294419

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 862 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-04
• Study Completion Date: 2022-09-30

Brief Summary

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

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.

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: OTHER

CVD Integrated Risk Test

Intervention Type: DEVICE

CVD IRT (Cardiovascular Integrated Risk Tool)

Interventions

CVD Integrated Risk Test

CVD IRT (Cardiovascular Integrated Risk Tool)

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Genomics PLC

INDUSTRY

Sponsor Role: lead

NHS North of England Commissioning Support (NECS)

UNKNOWN

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

A Fuat, Prof

Role: PRINCIPAL_INVESTIGATOR

Carmel Medical Practice

Locations

Carmel Medical Practice

Darlington, Co Durham, United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

GEN2020-02

Identifier Type: -

Identifier Source: org_study_id