N/A
Completed N=862
The Healthcare Evaluation of Absolute Risk Testing Study
Source: ClinicalTrials.gov NCT05294419 ↗Enrolled (actual)
862
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcomePrimary: Feasibility: Count of Participants Who Were Successfully Returned a Result — 832 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility: Count of Participants Who Were Successfully Returned a Result |
832 | — |
| PRIMARY HCP Perception: Count of HCPs Recommending Test (End-of-study Questionnaire) |
17 | — |
| PRIMARY HCP Perception: Count of Favourable Ease-of-use Responses (Post-results Questionnaire) |
747 | — |
| PRIMARY Participant Satisfaction: Count of Participants Recommending Test in Post-results Questionnaire |
452 | — |
| PRIMARY Participant Satisfaction: Count of Participants Who Found Test Useful in Post-results Questionnaire |
514 | — |
| PRIMARY Participant Satisfaction: Count of Participants Who Found Test Easy to Understand in Post-results Questionnaire |
492 | — |
| PRIMARY Feasibility: Result Return Time |
60 | — |
| SECONDARY Risk Reclassification Counts |
43; 43; 118; 628 | — |
| SECONDARY CVD-IRT Mean Value |
6.6 | — |
| SECONDARY HCP Impact: Count of Changed Management Decisions (Post-results Questionnaire) |
108 | — |
| SECONDARY Participant Perception: Count of Participants Who Agreed Genetics is Important in Post-results Questionnaire |
443 | — |
| SECONDARY Correlation in Saliva-derived and Blood-derived CVD-IRT Scores |
0.999 | — |
| SECONDARY Safety: Count of Participants Reporting Device Related Adverse Events or Deficiencies |
— | — |
| SECONDARY QRISK®2 Mean Value |
6.4 | — |
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.
Data sourced from ClinicalTrials.gov (NCT05294419). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.