Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Heart disease screening with AI-enabled ECG and focused ultrasound

Official title: Screening for Heart Disease Using AI-Enabled Electrocardiography and Focused Cardiac Ultrasound: the AI CVD Screen Study.

Run by Mayo Clinic · NCT07351656 · Data updated 2026-11-12

This study tests whether AI-powered ECGs and focused cardiac ultrasound can screen for heart disease in well-described community groups.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment19300 (estimated)
SponsorMayo Clinic
Academic / other
Locations1 site (Rochester, Minnesota)
StatusRecruiting
StartedMarch 9, 2026
Main results expectedFebruary 2028
Study endsFebruary 2028
Registry record updatedAugust 20, 2026
Trial IDNCT07351656 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adolescents and young adults (18–29) in MN high schools or colleges, community-dwelling adults over 30, and pregnant women aged 18–49 receiving obstetric care at Mayo Clinic sites.

Probably not a fit

Individuals unable to provide informed consent or who cannot obtain a quality ECG tracing may not benefit from the screening.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial will use 6-lead AI-ECG and AI FoCUS ultrasound to screen for cardiac disease in adolescents, young adults, community-dwelling adults, and pregnant women at Mayo Clinic locations in Rochester, MN. It aims to determine feasibility, diagnostic yield, accuracy, and actionable thresholds with immediate feedback. Participants must meet age and consent criteria and exclude those with pacemakers or poor-quality ECGs. The study is interventional but does not specify a traditional randomization or control group. Enrollment spans multiple demographic subgroups to assess broad applicability in real-world settings.

Why it matters

Potential benefit: If successful, the approach could enable faster, noninvasive cardiac screening with immediate results.

How similar studies have gone: Previous work in AI-ECG and point-of-care ultrasound has shown promise in screening, but this combination in broad community populations is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Adolescents and young adults:

Inclusion Criteria:

* Enrollment in a high-school, college or a resident in MN during the study period
* Age 18-29 years
* Informed consent (and assent for minors)

Exclusion Criteria:

* Presence of a pacemaker or defibrillator
* Inability to obtain a quality ECG tracing

Community dwelling adults:

Inclusion Criteria:

• Adult patients (\>30 years of age, with pre-specified subgroups 30-64 and 65+))

Exclusion Criteria:

• Inability to provide informed consent to participate in the study

Pregnant women:

Inclusion Criteria:

* Adult female aged 18 to 49 years
* Pregnant at the time of enrollment
* Receiving obstetric care at identified study site(s)
* Willing and able to provide informed consent

Exclusion Criteria:

• Inability to provide consent

Where it's running

  • Mayo Clinic in Rochester
    Rochester, Minnesota, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.