The Healthcare Evaluation of Absolute Risk Testing Study

NCT05294419 | Completed Results

• 1 other identifier: GEN2020-02
• Study Type: interventional
• Target: 862
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (7)

• Feasibility: Count of Participants Who Were Successfully Returned a Result

  Count of non-withdrawn participants (in "Participants Receiving CVD-IRT" arm) who were successfully returned a CVD-IRT result

  1.3-8.9 months from baseline (study enrolment)

• HCP Perception: Count of HCPs Recommending Test (End-of-study Questionnaire)

  Count of healthcare professionals responding "likely" or "very likely" in 5-point Likert response scale ("very unlikely" / "unlikely" / "undecided" / "likely" / "very likely") to the question "Would you recommend the test to colleagues in other practices?'" in HCP end-of-study questionnaire.

  End of study (8-10 months after start of study)

• HCP Perception: Count of Favourable Ease-of-use Responses (Post-results Questionnaire)

  Count of "Yes" responses to the statement "The CVD-IRT can be incorporated into routine primary care in a straightforward manner" in the HCP post-results questionnaire (separate questionnaire filled at the time each CVD-IRT result was returned to participants)

  1.3-8.9 months from baseline (study enrolment)

• Participant Satisfaction: Count of Participants Recommending Test in Post-results Questionnaire

  Count of participants responding "likely" or "very likely" in Likert 5-point response scale ("very unlikely" / "unlikely" / "undecided" / "likely" / "very likely") to the question "How likely would you be to recommend the use of this test to friends or family in similar situations?" in the questionnaire given to participants after receiving their CVD-IRT results

  1.3-10 months from baseline (study enrolment)

• Participant Satisfaction: Count of Participants Who Found Test Useful in Post-results Questionnaire

  Count of participants responding "Yes" to the question "Did you personally find this test useful?" in the questionnaire given to participants after receiving their CVD-IRT results

  1.3-10 months from baseline (study enrolment)

• Participant Satisfaction: Count of Participants Who Found Test Easy to Understand in Post-results Questionnaire

  Count of participants responding "Yes" to the question "Were the results easy to understand?" in the questionnaire given to participants after receiving their CVD-IRT results

  1.3-10 months from baseline (study enrolment)

• Feasibility: Result Return Time

  Time (in days) between study enrolment and receiving a CVD-IRT result (for participants in "Participants Receiving CVD-IRT" arm)

  1.3-8.9 months from baseline (study enrolment)

Secondary Outcomes (7)

• Risk Reclassification Counts

  1.3-8.9 months from baseline (study enrolment)

• CVD-IRT Mean Value

  1.3-8.9 months from baseline (study enrolment)

• HCP Impact: Count of Changed Management Decisions (Post-results Questionnaire)

  1.3-8.9 months from baseline (study enrolment)

• Participant Perception: Count of Participants Who Agreed Genetics is Important in Post-results Questionnaire

  1.3-10 months from baseline (study enrolment)

• Correlation in Saliva-derived and Blood-derived CVD-IRT Scores

  End of study (8-10 months after start of study)

Study Arms (1)

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

OTHER

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

Device: CVD Integrated Risk Test

Interventions

CVD Integrated Risk Test DEVICE

CVD IRT (Cardiovascular Integrated Risk Tool)

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

Eligibility Criteria

• Age: 45 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Those excluded from NHS Health Checks;
• Currently prescribed and taking HMG-CoA reductase inhibitors (lipid-lowering preventive treatments or statins) for any indication.

Sponsors & Collaborators

• NHS North of England Commissioning Support (NECS): collaborator
• Genomics PLC: lead

Study Sites (1)

Carmel Medical Practice

Darlington, Co Durham, DL3 8SQ, United Kingdom

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Limitations and Caveats

Planned rather than conducted changes in management practices were evaluated. Per protocol, HCPs delivered standard of care if the IRT produced a lower 10-year risk than QRISK. As a consequence, we did not assess potential changes in management when the inclusion of the PRS reduced overall risk. This study did not include an independent control group, so references to association only, rather than causation, regarding clinical decision making may be stated here.

Results Point of Contact

• Title: Seamus Harrison
• Organization: Genomics Ltd

seamus.harrison@genomics.com

+44 1865 981600

Study Officials

• A Fuat, Prof

  Carmel Medical Practice

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: March 24, 2022
• Study Start: November 4, 2021
• Primary Completion: August 31, 2022
• Study Completion: September 30, 2022
• Last Updated: December 8, 2025
• Results First Posted: December 8, 2025

Record last verified: 2025-12

Locations

GB (1)