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Genetic test could predict heart risk before it strikes

NCT ID NCT06542432

Knowledge-focused Sponsor: MyOme Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looks at whether giving people a personalized genetic risk score for coronary artery disease helps doctors make better decisions about prevention. About 1,000 adults with moderate heart risk will be randomly assigned to receive their risk score or not. Researchers will track if the score leads to more use of cholesterol-lowering drugs or heart tests, and whether it lowers cholesterol levels or heart attacks over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
polygenic risk score (genetic test)
What this could lead to
If successful, this could help doctors identify people at higher risk for heart disease earlier and guide preventive treatments like cholesterol-lowering medications.
What could go wrong
This is an observational study, not a treatment trial. The risk score may not significantly change doctor behavior or improve health outcomes, and results may not apply to all populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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)

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder coronary artery disorder Coronary Disease Genetic Risk Score heart disorder myocardial infarction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular diseases Coronary artery disease Coronary disease Heart diseases Myocardial infarction Polygenic risk score

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.