Coronary Artery DiseaseNCT06542432
Utility and Effectiveness of Polygenic Risk Scoring (PRS) for Coronary Artery Disease (CAD)
A study testing Disclosure of integrate risk score for coronary artery disease in people with Coronary Artery Disease and Polygenic Risk Score, run by MyOme at 2 sites in United States.
Trial summary
The goal of this study is to assess the benefit to physicians and patients of adding an integrated risk score (IRS) to existing coronary artery risk tools by conducting a randomized prospective study. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Coronary Artery Disease, Polygenic Risk Score, Heart Diseases
- What is being tested?
- Disclosure of integrate risk score for coronary artery disease
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2025to 1 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASCVD risk ≥5% and below 20% over the following 10 years as defined by the standard pooled cohort equations
- No previous CAD event (inclusive of myocardial infarction, diagnosis of CAD, stroke)
- Previously genotyped as part of a research study that enables recontact of participants
- Receiving primary care at a participating institution.
Who cannot join
- Prior diagnosis of CAD: inclusive of prior myocardial infarction and revascularization (stent or coronary artery bypass grafting)
- Currently treated with lipid-lowering therapy, including statins, ezetimibe, PCSK9 inhibitors, inclisiran, or bempedoic acid
- Future use of statins contraindicated
- Prior diagnosis of Cerebrovascular disease: Inclusive of history of ischemic stroke, transient ischaemic attack (TIA), carotid endarterectomy, carotid artery stenting
- Prior diagnosis of Peripheral arterial disease: Inclusive of history of claudication, revascularization (stents or bypass)
- Severe hypercholesterolemia (LDL-C ≥ 190 mg/dL)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: A Prospective Trial to Assess Clinical Utility and Effectiveness of MyOme's Polygenic Risk Score for Coronary Artery Disease (COMPASS-CAD)
The goal of this study is to assess the benefit to physicians and patients of adding an integrated risk score (IRS) to existing coronary artery risk tools by conducting a randomized prospective study. IRS combines both an individual's coronary artery disease (CAD) polygenic risk score (PRS) and clinical risk factors, like cholesterol levels and age. This study will examine to what extent IRS knowledge impacts physician/provider behavior as well as clinical outcomes including cholesterol levels and incident heart disease.
Read the detailed description
This is a 1:1 randomized controlled trial of participants with no known coronary artery disease, are not on lipid-lowering therapy, and do not have LDL-C over 190mg/dL. Participants will be recruited from cohorts that have been previously genotyped and found to have either elevated or average risk based on a CAD IRS. Participants will be randomized into two equal groups: one group will receive their IRS result for coronary artery disease at baseline, and the other group will receive their ASCVD Pooled Cohorts Equation result at baseline and CAD IRS result approximately 3 years after enrollment. Subject data will be collected for 5 years from the time of enrollment.
- Conditions
- Coronary Artery Disease, Polygenic Risk Score, Heart Diseases, Coronary Disease, Myocardial Infarction, Cardiovascular Diseases
- Being tested
- Disclosure of integrate risk score for coronary artery disease
- Keywords
- Polygenic risk score, Integrated risk score, Genetics, Cardiovascular health, Coronary artery disease, Precision medicine
- Medical subject headings
- Coronary Artery Disease, Genetic Risk Score, Heart Diseases, Coronary Disease, Myocardial Infarction, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disclosure of integrate risk score for coronary artery diseaseGenetic
Participants will receive their integrated risk score for coronary disease along with an optional genetic counseling visit to discuss the results.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Intervention | Experimental | Participants will receive their integrated risk score result for coronary artery disease. Receives: Genetic: Disclosure of integrate risk score for coronary artery disease |
| No Intervention: Control | No intervention | Participants will only receive standard of care ASCVD Pooled Cohorts Equation (ASCVD PCE), and disclosure of integrated risk score result will be deferred until 3 years after enrollment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Does receiving an IRS report influence clinical decision making, including the provider's decision to treat with lipid lowering medication or order diagnostic testing?
Aggregating longitudinal clinical data will be collected to compare the incidence of lipid-lowering medication initiation and cardiac diagnostic testing between the intervention arm which received their integrated risk score and the control group.
Measured: 5 years
Does receiving an IRS report affect patient clinical measurements, including LDL-C levels?
Aggregating longitudinal clinical data will be collected to compare the clinical measurements between the intervention arm which received their integrated risk score and the control group.
Measured: 5 years
Secondary outcomes (3)
Does the IRS identify those at elevated risk for CAD and future ASCVD events?
Aggregated longitudinal clinical data and patient survey data will be collected to compare patient clinical outcomes in those with a high CAD IRS.
Measured: 5 years
Does receiving an IRS report affect the incidence of CAD events?
Aggregated longitudinal clinical data will be collected to compare patient clinical outcomes in those with a CAD IRS reported at baseline and the control group.
Measured: 5 years
Does receiving an IRS report affect participant understanding of their individual CAD risk?
Patient survey data will be collected to assess their understanding of their CAD risk.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Jan 2025
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MyOme
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania, Mayo Clinic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542432
- Sponsor's protocol ID
- 004
- Status last verified
- Sep 2025
- First submitted
- 29 Mar 2024
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial to Assess Clinical Utility and Effectiveness of MyOme's Polygenic Risk Score for Coronary Artery Disease (COMPASS-CAD)
- ClinicalTrials.gov ID
- NCT06542432
- Acronym / sponsor ID
- 004
- Conditions
- Coronary Artery Disease, Polygenic Risk Score, Heart Diseases, Coronary Disease, Myocardial Infarction, Cardiovascular Diseases
- Keywords
- Polygenic risk score, Integrated risk score, Genetics, Cardiovascular health, Coronary artery disease, Precision medicine
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- MyOmeIndustry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania, Mayo Clinic
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to assess the benefit to physicians and patients of adding an integrated risk score (IRS) to existing coronary artery risk tools by conducting a randomized prospective study. IRS combines both an individual's coronary artery disease (CAD) polygenic risk score (PRS) and clinical risk factors, like cholesterol levels and age. This study will examine to what extent IRS knowledge impacts physician/provider behavior as well as clinical outcomes including cholesterol levels and incident heart disease.
Detailed description
This is a 1:1 randomized controlled trial of participants with no known coronary artery disease, are not on lipid-lowering therapy, and do not have LDL-C over 190mg/dL. Participants will be recruited from cohorts that have been previously genotyped and found to have either elevated or average risk based on a CAD IRS. Participants will be randomized into two equal groups: one group will receive their IRS result for coronary artery disease at baseline, and the other group will receive their ASCVD Pooled Cohorts Equation result at baseline and CAD IRS result approximately 3 years after enrollment. Subject data will be collected for 5 years from the time of enrollment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention | Experimental | Genetic: Disclosure of integrate risk score for coronary artery diseaseParticipants will receive their integrated risk score result for coronary artery disease. |
| No Intervention: Control | No intervention | –Participants will only receive standard of care ASCVD Pooled Cohorts Equation (ASCVD PCE), and disclosure of integrated risk score result will be deferred until 3 years after enrollment. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASCVD risk ≥5% and below 20% over the following 10 years as defined by the standard pooled cohort equations
- No previous CAD event (inclusive of myocardial infarction, diagnosis of CAD, stroke)
- Previously genotyped as part of a research study that enables recontact of participants
- Receiving primary care at a participating institution.
Key exclusion criteria (6 listed)
- Prior diagnosis of CAD: inclusive of prior myocardial infarction and revascularization (stent or coronary artery bypass grafting)
- Currently treated with lipid-lowering therapy, including statins, ezetimibe, PCSK9 inhibitors, inclisiran, or bempedoic acid
- Future use of statins contraindicated
- Prior diagnosis of Cerebrovascular disease: Inclusive of history of ischemic stroke, transient ischaemic attack (TIA), carotid endarterectomy, carotid artery stenting
- Prior diagnosis of Peripheral arterial disease: Inclusive of history of claudication, revascularization (stents or bypass)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disclosure of integrate risk score for coronary artery diseaseParticipants will receive their integrated risk score for coronary disease along with an optional genetic counseling visit to discuss the results. | Genetic | Experimental: Intervention |
Primary outcome
Does receiving an IRS report influence clinical decision making, including the provider's decision to treat with lipid lowering medication or order diagnostic testing?
Time frame: 5 years
Aggregating longitudinal clinical data will be collected to compare the incidence of lipid-lowering medication initiation and cardiac diagnostic testing between the intervention arm which received their integrated risk score and the control group.
Does receiving an IRS report affect patient clinical measurements, including LDL-C levels?
Time frame: 5 years
Aggregating longitudinal clinical data will be collected to compare the clinical measurements between the intervention arm which received their integrated risk score and the control group.
3 secondary outcomes
Does the IRS identify those at elevated risk for CAD and future ASCVD events?
Time frame: 5 years
Does receiving an IRS report affect the incidence of CAD events?
Time frame: 5 years
Does receiving an IRS report affect participant understanding of their individual CAD risk?
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disclosure of integrate risk score for coronary artery disease in people with Coronary Artery Disease and Polygenic Risk Score, run by MyOme at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Does receiving an IRS report influence clinical decision making, including the provider's decision to treat with lipid lowering medication or order diagnostic testing? (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.