Trial Outcomes & Findings for The Healthcare Evaluation of Absolute Risk Testing Study (NCT NCT05294419)

NCT ID: NCT05294419

Last Updated: 2025-12-08

Results Overview

Count of non-withdrawn participants (in "Participants Receiving CVD-IRT" arm) who were successfully returned a CVD-IRT result

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 862 participants
• Primary outcome timeframe: 1.3-8.9 months from baseline (study enrolment)
• Results posted on: 2025-12-08

Participant Flow

The study enrolled 836 participants from 12 sites, of which 832 participated in the analyses by providing blood samples and answering questionnaires. Of these participants 21 took part in the telephone interview. 23 HCPs took part in the final questionnaire, 12 HCPs took part in focus groups and 1 HCP completed an interview. Two PCCs took part in a focus group and 1 PCC completed an interview.

Participant milestones

Measure	Participants Receiving CVD-IRT Enrolled participants who elected to receive a CVD-IRT (Integrated Risk Tool reporting 10-year risk of CVD based on both QRISK2 and a PRS for CVD) as part of this study	Healthcare Professionals (HCPs) HCPs who delivered CVD-IRT information to participants as part of this study	Primary Care Commissioners (PCCs) PCCs who took part in this study (via focus group or interview)
Overall Study STARTED	836	23	3
Overall Study COMPLETED	824	23	3
Overall Study NOT COMPLETED	12	0	0

Reasons for withdrawal

Measure	Participants Receiving CVD-IRT Enrolled participants who elected to receive a CVD-IRT (Integrated Risk Tool reporting 10-year risk of CVD based on both QRISK2 and a PRS for CVD) as part of this study	Healthcare Professionals (HCPs) HCPs who delivered CVD-IRT information to participants as part of this study	Primary Care Commissioners (PCCs) PCCs who took part in this study (via focus group or interview)
Overall Study Protocol Violation	4	0	0
Overall Study Lost to Follow-up	6	0	0
Overall Study Results voided after publishing	2	0	0

Baseline Characteristics

The Healthcare Evaluation of Absolute Risk Testing Study

Baseline characteristics by cohort

Measure	Participants Receiving CVD-IRT n=836 Participants Enrolled participants who elected to receive a CVD-IRT (Integrated Risk Tool reporting 10-year risk of CVD based on both QRISK2 and a PRS for CVD) as part of this study.
Age, Continuous	54.7 years STANDARD_DEVIATION 5.6 • n=37 Participants
Sex: Female, Male Female	518 Participants n=37 Participants
Sex: Female, Male Male	318 Participants n=37 Participants
Race/Ethnicity, Customized White	813 Participants n=37 Participants
Race/Ethnicity, Customized Mixed Multiple	4 Participants n=37 Participants
Race/Ethnicity, Customized Asian/ Asian British	11 Participants n=37 Participants
Race/Ethnicity, Customized Black: Africa/ Black Caribbean/ Black british	4 Participants n=37 Participants
Race/Ethnicity, Customized Other	2 Participants n=37 Participants
Race/Ethnicity, Customized NA	2 Participants n=37 Participants
Region of Enrollment United Kingdom	836 participants n=37 Participants

PRIMARY outcome

Timeframe: 1.3-8.9 months from baseline (study enrolment)

Population: 836 were enrolled, 4 participants either withdrew or did not provide a sample for analysis

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

Outcome measures

Measure	Participants Receiving CVD-IRT n=832 Participants Enrolled participants who elected to receive a CVD-IRT (Integrated Risk Tool reporting 10-year risk of CVD based on both QRISK2 and a PRS for CVD) as part of this study
Feasibility: Count of Participants Who Were Successfully Returned a Result	832 Participants

PRIMARY outcome

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

Population: HCPs who delivered CVD-IRT information to participants as part of this 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.

Outcome measures

Measure	Participants Receiving CVD-IRT n=23 Participants Enrolled participants who elected to receive a CVD-IRT (Integrated Risk Tool reporting 10-year risk of CVD based on both QRISK2 and a PRS for CVD) as part of this study
HCP Perception: Count of HCPs Recommending Test (End-of-study Questionnaire)	17 Participants

PRIMARY outcome

Timeframe: 1.3-8.9 months from baseline (study enrolment)

Population: HCPs who delivered CVD-IRT information to participants as part of this study. A separate questionnaire was filled in every time a CVD-IRT result was returned.

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)

Outcome measures

Measure	Participants Receiving CVD-IRT n=824 CVD-IRT results returned Enrolled participants who elected to receive a CVD-IRT (Integrated Risk Tool reporting 10-year risk of CVD based on both QRISK2 and a PRS for CVD) as part of this study
HCP Perception: Count of Favourable Ease-of-use Responses (Post-results Questionnaire)	747 CVD-IRT results returned

PRIMARY outcome

Timeframe: 1.3-10 months from baseline (study enrolment)

Population: 520 participants responded after they received their CVD-IRT result, through an on-line survey.

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

Outcome measures

Measure	Participants Receiving CVD-IRT n=520 Participants Enrolled participants who elected to receive a CVD-IRT (Integrated Risk Tool reporting 10-year risk of CVD based on both QRISK2 and a PRS for CVD) as part of this study
Participant Satisfaction: Count of Participants Recommending Test in Post-results Questionnaire	452 Participants

PRIMARY outcome

Timeframe: 1.3-10 months from baseline (study enrolment)

Population: 520 participants responded after they received their CVD-IRT result, through an on-line survey

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

Outcome measures

Measure	Participants Receiving CVD-IRT n=520 Participants Enrolled participants who elected to receive a CVD-IRT (Integrated Risk Tool reporting 10-year risk of CVD based on both QRISK2 and a PRS for CVD) as part of this study
Participant Satisfaction: Count of Participants Who Found Test Useful in Post-results Questionnaire	514 Participants

PRIMARY outcome

Timeframe: 1.3-10 months from baseline (study enrolment)

Population: 520 participants responded after they received their CVD-IRT result, through an on-line survey

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

Outcome measures

Measure	Participants Receiving CVD-IRT n=520 Participants Enrolled participants who elected to receive a CVD-IRT (Integrated Risk Tool reporting 10-year risk of CVD based on both QRISK2 and a PRS for CVD) as part of this study
Participant Satisfaction: Count of Participants Who Found Test Easy to Understand in Post-results Questionnaire	492 Participants

PRIMARY outcome

Timeframe: 1.3-8.9 months from baseline (study enrolment)

Population: 836 were enrolled, 4 participants either withdrew or did not provide a sample for analysis

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

Outcome measures

Measure	Participants Receiving CVD-IRT n=832 Participants Enrolled participants who elected to receive a CVD-IRT (Integrated Risk Tool reporting 10-year risk of CVD based on both QRISK2 and a PRS for CVD) as part of this study
Feasibility: Result Return Time	60 days Interval 55.0 to 66.0

SECONDARY outcome

Timeframe: 1.3-8.9 months from baseline (study enrolment)

Population: 836 were enrolled, 4 participants either withdrew or did not provide a sample for analysis

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%).

Outcome measures

Measure	Participants Receiving CVD-IRT n=832 Participants Enrolled participants who elected to receive a CVD-IRT (Integrated Risk Tool reporting 10-year risk of CVD based on both QRISK2 and a PRS for CVD) as part of this study
Risk Reclassification Counts Up-classified to high risk (CVD-IRT≥10%, QRISK®2<10%)	43 Participants
Risk Reclassification Counts Down-classified to low risk (CVD-IRT<10%, QRISK®2≥10%)	43 Participants
Risk Reclassification Counts Remained high risk for both CVD-IRT and QRISK®2 (≥10%)	118 Participants
Risk Reclassification Counts Remained low risk for both CVD-IRT and QRISK®2 (<10%)	628 Participants

SECONDARY outcome

Timeframe: 1.3-8.9 months from baseline (study enrolment)

Population: 836 were enrolled, 4 participants either withdrew or did not provide a sample for analysis

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

Outcome measures

Measure	Participants Receiving CVD-IRT n=832 Participants Enrolled participants who elected to receive a CVD-IRT (Integrated Risk Tool reporting 10-year risk of CVD based on both QRISK2 and a PRS for CVD) as part of this study
CVD-IRT Mean Value	6.6 percentage risk Interval 0.3 to 37.8

SECONDARY outcome

Timeframe: 1.3-8.9 months from baseline (study enrolment)

Population: HCPs who delivered CVD-IRT information to participants as part of this study. A separate questionnaire was filled in every time a CVD-IRT result was returned. This question was only posed if CVD-IRT\<QRISK2, a condition which was met for 388 results.

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

Outcome measures

Measure	Participants Receiving CVD-IRT n=388 CVD-IRT>QRISK2 results Enrolled participants who elected to receive a CVD-IRT (Integrated Risk Tool reporting 10-year risk of CVD based on both QRISK2 and a PRS for CVD) as part of this study
HCP Impact: Count of Changed Management Decisions (Post-results Questionnaire)	108 CVD-IRT>QRISK2 results

SECONDARY outcome

Timeframe: 1.3-10 months from baseline (study enrolment)

Population: 520 participants responded after they received their CVD-IRT result, through an on-line survey

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

Outcome measures

Measure	Participants Receiving CVD-IRT n=520 Participants Enrolled participants who elected to receive a CVD-IRT (Integrated Risk Tool reporting 10-year risk of CVD based on both QRISK2 and a PRS for CVD) as part of this study
Participant Perception: Count of Participants Who Agreed Genetics is Important in Post-results Questionnaire	443 Participants

SECONDARY outcome

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

Population: 91 participants donated a saliva sample in addition to the blood sample which was the primary DNA collection method in this 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

Outcome measures

Measure	Participants Receiving CVD-IRT n=91 Participants Enrolled participants who elected to receive a CVD-IRT (Integrated Risk Tool reporting 10-year risk of CVD based on both QRISK2 and a PRS for CVD) as part of this study
Correlation in Saliva-derived and Blood-derived CVD-IRT Scores	0.999 Pearson correlation coefficient

SECONDARY outcome

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

Population: 836 were enrolled, 4 participants either withdrew or did not provide a sample for analysis

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

Outcome measures

Measure	Participants Receiving CVD-IRT n=836 Participants Enrolled participants who elected to receive a CVD-IRT (Integrated Risk Tool reporting 10-year risk of CVD based on both QRISK2 and a PRS for CVD) as part of this study
Safety: Count of Participants Reporting Device Related Adverse Events or Deficiencies	0 Participants

SECONDARY outcome

Timeframe: Within 6 months of study enrolment

Population: 836 were enrolled, 4 participants either withdrew or did not provide a sample for analysis

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

Outcome measures

Measure	Participants Receiving CVD-IRT n=832 Participants Enrolled participants who elected to receive a CVD-IRT (Integrated Risk Tool reporting 10-year risk of CVD based on both QRISK2 and a PRS for CVD) as part of this study
QRISK®2 Mean Value	6.4 percentage risk Interval 0.6 to 35.5

Adverse Events

Participants Receiving CVD-IRT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Seamus Harrison

Genomics Ltd

Phone: +44 1865 981600

Email: seamus.harrison@genomics.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place