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| Name | Class |
|---|---|
| NHS North of England Commissioning Support (NECS) | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CVD Integrated Risk Test | Device | CVD IRT (Cardiovascular Integrated Risk Tool) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Risk Reclassification Counts | 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%). | 1.3-8.9 months from baseline (study enrolment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| A Fuat, Prof | Carmel Medical Practice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carmel Medical Practice | Darlington | Co Durham | DL3 8SQ | United Kingdom |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Healthcare Professionals (HCPs) | HCPs who delivered CVD-IRT information to participants as part of this study |
| FG002 | Primary Care Commissioners (PCCs) | PCCs who took part in this study (via focus group or interview) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline measurements were only recorded for the "Participants Receiving CVD-IRT" arm. Baseline measurements were not recorded for the "Healthcare professionals (HCPs)" and "Primary care commissioners (PCCs)" arms.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 836 were enrolled, 4 participants either withdrew or did not provide a sample for analysis | Posted | Count of Participants | Participants | 1.3-8.9 months from baseline (study enrolment) |
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From start of study to end of study (10 months after start of study)
The adverse event and device deficiency definitions were aligned to those in the international standard ISO 20916: 2019 for in vitro diagnostic medical devices. HCPs and PCCs were not monitored/assessed for Adverse Events per-protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Seamus Harrison | Genomics Ltd | +44 1865 981600 | seamus.harrison@genomics.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 6, 2021 | Sep 20, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 6, 2022 | Sep 20, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| 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) |
| CVD-IRT Mean Value | Mean risk score value (in the "Participants Receiving CVD-IRT" arm) of the CVD-IRT score | 1.3-8.9 months from baseline (study enrolment) |
| HCP Impact: Count of Changed Management Decisions (Post-results Questionnaire) | 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 | 1.3-8.9 months from baseline (study enrolment) |
| Participant Perception: Count of Participants Who Agreed Genetics is Important in Post-results Questionnaire | 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 | 1.3-10 months from baseline (study enrolment) |
| Correlation in Saliva-derived and Blood-derived CVD-IRT Scores | 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 | End of study (8-10 months after start of study) |
| Safety: Count of Participants Reporting Device Related Adverse Events or Deficiencies | Safety: Count of participants reporting device related adverse events or deficiencies | From start of study to end of study (10 months after start of study) |
| QRISK®2 Mean Value | Mean risk score value (in the "Participants Receiving CVD-IRT" arm) of the QRISK®2 score | Within 6 months of study enrolment |
| Results voided after publishing |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Primary | 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. | HCPs who delivered CVD-IRT information to participants as part of this study | Posted | Count of Participants | Participants | End of study (8-10 months after start of study) |
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| Primary | 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) | 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. | Posted | Count of Units | CVD-IRT results returned | 1.3-8.9 months from baseline (study enrolment) | CVD-IRT results returned | CVD-IRT results returned |
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| Primary | 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 | 520 participants responded after they received their CVD-IRT result, through an on-line survey. | Posted | Count of Participants | Participants | 1.3-10 months from baseline (study enrolment) |
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| Primary | 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 | 520 participants responded after they received their CVD-IRT result, through an on-line survey | Posted | Count of Participants | Participants | 1.3-10 months from baseline (study enrolment) |
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|
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| Primary | 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 | 520 participants responded after they received their CVD-IRT result, through an on-line survey | Posted | Count of Participants | Participants | 1.3-10 months from baseline (study enrolment) |
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| Primary | Feasibility: Result Return Time | Time (in days) between study enrolment and receiving a CVD-IRT result (for participants in "Participants Receiving CVD-IRT" arm) | 836 were enrolled, 4 participants either withdrew or did not provide a sample for analysis | Posted | Median | Inter-Quartile Range | days | 1.3-8.9 months from baseline (study enrolment) |
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| Secondary | Risk Reclassification Counts | 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%). | 836 were enrolled, 4 participants either withdrew or did not provide a sample for analysis | Posted | Count of Participants | Participants | 1.3-8.9 months from baseline (study enrolment) |
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| Secondary | CVD-IRT Mean Value | Mean risk score value (in the "Participants Receiving CVD-IRT" arm) of the CVD-IRT score | 836 were enrolled, 4 participants either withdrew or did not provide a sample for analysis | Posted | Mean | Full Range | percentage risk | 1.3-8.9 months from baseline (study enrolment) |
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| Secondary | HCP Impact: Count of Changed Management Decisions (Post-results Questionnaire) | 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 | 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\ | Posted | Count of Units | CVD-IRT>QRISK2 results | 1.3-8.9 months from baseline (study enrolment) | CVD-IRT>QRISK2 results | CVD-IRT>QRISK2 results |
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| Secondary | Participant Perception: Count of Participants Who Agreed Genetics is Important in Post-results Questionnaire | 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 | 520 participants responded after they received their CVD-IRT result, through an on-line survey | Posted | Count of Participants | Participants | 1.3-10 months from baseline (study enrolment) |
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| Secondary | Correlation in Saliva-derived and Blood-derived CVD-IRT Scores | 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 | 91 participants donated a saliva sample in addition to the blood sample which was the primary DNA collection method in this study | Posted | Number | Pearson correlation coefficient | End of study (8-10 months after start of study) |
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| Secondary | Safety: Count of Participants Reporting Device Related Adverse Events or Deficiencies | Safety: Count of participants reporting device related adverse events or deficiencies | 836 were enrolled, 4 participants either withdrew or did not provide a sample for analysis | Posted | Count of Participants | Participants | From start of study to end of study (10 months after start of study) |
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| Secondary | QRISK®2 Mean Value | Mean risk score value (in the "Participants Receiving CVD-IRT" arm) of the QRISK®2 score | 836 were enrolled, 4 participants either withdrew or did not provide a sample for analysis | Posted | Mean | Full Range | percentage risk | Within 6 months of study enrolment |
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| 0 |
| 836 |
| 0 |
| 836 |
| 0 |
| 836 |
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| Remained low risk for both CVD-IRT and QRISK®2 (<10%) |
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