The Healthcare Evaluation of Absolute Risk Testing Study

Cardiovascular Diseases Clinical Trial

— HEART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05294419
• Other study ID #: GEN2020-02
• Status: Completed
• Phase: N/A
• Start date: November 4, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: February 2023
• Source: Genomics PLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 836
• Est. completion date: September 30, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Device:
• CVD Integrated Risk Test
CVD IRT (IVD regulations with a software device)

Locations

Country	Name	City	State
United Kingdom	Carmel Medical Practice	Darlington	Co Durham

Sponsors (2)

Lead Sponsor	Collaborator
Genomics PLC	NHS North of England Commissioning Support (NECS)

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Usefulness of CVD IRT	HCP questionnaires based on a likert scale	HCP questionnaires within 2 months of last participant CVD-IRT reported
Other	Usefulness of CVD IRT	HCP focus groups based on interview exploring themes in the questionnaires	HCP focus groups within 2 months of last participant CVD-IRT reported
Other	Future development of genetic risk tests	PCC focus group based on interview exploring themes in the questionnaires	PCC focus groups within 2 months of last participant CVD-IRT reported
Primary	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
Primary	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 )
Primary	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	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Safety of CVD-IRT	Reporting of AE and device related deficiencies	Participant visit 1 to last participant interview or withdrawal