Skip to main content
OpenTrials
Completed

NCT Number: NCT05294419

The Healthcare Evaluation of Absolute Risk Testing Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiovascular Diseases

Age range

45 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carmel Medical Practice

Darlington, Co Durham, DL3 8SQ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CVD Integrated Risk Test

Device

CVD IRT (Cardiovascular Integrated Risk Tool)

Primary outcomes

  1. Feasibility: Count of Participants Who Were Successfully Returned a Result

    Time frame: 1.3-8.9 months from baseline (study enrolment)

    Count of non-withdrawn participants (in "Participants Receiving CVD-IRT" arm) who were successfully returned a CVD-IRT result

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

    Time frame: End of study (8-10 months after start of study)

    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.

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

    Time frame: 1.3-8.9 months from baseline (study enrolment)

    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)

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

    Time frame: 1.3-10 months from baseline (study enrolment)

    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

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

    Time frame: 1.3-10 months from baseline (study enrolment)

    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

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

    Time frame: 1.3-10 months from baseline (study enrolment)

    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

  7. Feasibility: Result Return Time

    Time frame: 1.3-8.9 months from baseline (study enrolment)

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

Secondary outcomes

  1. Risk Reclassification Counts

    Time frame: 1.3-8.9 months from baseline (study enrolment)

    Count of participants (in the "Participants Receiving CVD-IRT" arm) up-classified by the CVD-IRT (CVD-IRT≥10%, QRISK®2<10%) / down-classified by the CVD-IRT (CVD-IRT<10%, QRISK®2≥10%) / remained high risk (CVD-IRT≥10%, QRISK®2≥10%) / remained low risk (CVD-IRT<10%, QRISK®2<10%).

  2. CVD-IRT Mean Value

    Time frame: 1.3-8.9 months from baseline (study enrolment)

    Mean risk score value (in the "Participants Receiving CVD-IRT" arm) of the CVD-IRT score

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

    Time frame: 1.3-8.9 months from baseline (study enrolment)

    Count of "Yes" responses to the statement "If the participant's CVD IRT score was greater than the participant's QRISK2 score, did this influence your management decision?" in the HCP post-results questionnaire (separate questionnaire filled at the time each CVD-IRT result was returned to participants) - responses were only recorded if CVD-IRT> QRISK2

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

    Time frame: 1.3-10 months from baseline (study enrolment)

    Count of participants responding "agree" or "strongly agree" in Likert 5-point response scale ("strongly disagree" / "disagree" / "neither agree not disagree" / "agree" / "strongly agree") to the statement "When it comes to the risk of developing heart disease, genetics are as important to measure as factors such as blood pressure" in the questionnaire given to participants after receiving their CVD-IRT results

  5. Correlation in Saliva-derived and Blood-derived CVD-IRT Scores

    Time frame: End of study (8-10 months after start of study)

    Some participants donated a saliva sample in addition to the blood sample (the primary DNA collection method used in this study). At the end of the study, CVD-IRT scores were also calculated from the saliva samples, and these were correlated against the blood-derived CVD-IRT scores

  6. Safety: Count of Participants Reporting Device Related Adverse Events or Deficiencies

    Time frame: From start of study to end of study (10 months after start of study)

    Safety: Count of participants reporting device related adverse events or deficiencies

  7. QRISK®2 Mean Value

    Time frame: Within 6 months of study enrolment

    Mean risk score value (in the "Participants Receiving CVD-IRT" arm) of the QRISK®2 score

Sponsors and collaborators

Lead sponsor

Genomics PLC

Industry

Collaborators

  • NHS North of England Commissioning Support (NECS)

Registry information

Official study title

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

Acronym: HEART

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 24, 2022
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.