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 type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 19300 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Status | Recruiting |
| Started | March 9, 2026 |
| Main results expected | February 2028 |
| Study ends | February 2028 |
| Registry record updated | August 20, 2026 |
| Trial ID | NCT07351656 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
- Principal investigator: Paul Friedman, MD — Mayo Clinic
- Study coordinator: Amanda Priebe
- Email: Priebe.Amanda@mayo.edu
- Phone: 507-422-6932
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.