Actively Recruiting
Screening for Heart Disease Using AI-Enabled Electrocardiography and Focused Cardiac Ultrasound: the AI CVD Screen Study
Led by Mayo Clinic · Updated on 2026-05-14
19300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of AI-enabled electrocardiography (AI-ECG) and focused cardiac ultrasound (FoCUS) to screen for heart disease in different community populations. The study aims to assess the feasibility, diagnostic accuracy, and actionable results of point-of-care immediate-feedback AI-ECG combined with AI FoCUS screening. The populations include adolescents and young adults, community-dwelling adults, and pregnant women. Participants will undergo diagnostic tests including a 6-lead AI-ECG, a 12-lead AI-ECG, and focused cardiac ultrasound using sonography to assess heart functions such as ventricular function, pericardial effusion, and valvular abnormalities. The study includes three groups: community adults over 30 years old, pregnant women aged 18 to 49 receiving obstetric care, and adolescents and young adults aged 15 to 29 years. Each group will be screened using these AI-assisted cardiac tests. During the study, participants will have ECGs and ultrasounds performed to detect cardiac abnormalities. Researchers will measure how often AI-ECG findings are confirmed by echocardiography and the number of correct AI-ECG diagnoses of significant cardiac disease. They will also track false positives and diagnoses of specific heart conditions. Safety events in pregnant women will be monitored. The study involves baseline evaluations and will continue through the study period ending in early 2028.
CONDITIONS
Brief Title
A Study Of Heart Disease Using AI-Enabled Electrocardiography And Focused Cardiac Ultrasound
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Enrollment in a high-school, college, or residency in Minnesota during the study period (for adolescents and young adults)
- Age 15 to 29 years (for adolescents and young adults)
- Able and willing to provide informed consent (and assent if minor) (for adolescents and young adults)
- Adults over 30 years of age (with subgroups 30-64 and 65+) (for community dwelling adults)
- Adult female aged 18 to 49 years who is pregnant at enrollment
- Receiving obstetric care at specified study sites (for pregnant women)
- Able and willing to provide informed consent (for pregnant women)
You will not qualify if you...
- Presence of a pacemaker or defibrillator (for adolescents and young adults)
- Inability to obtain a quality ECG tracing (for adolescents and young adults)
- Unable to provide informed consent (for community dwelling adults and pregnant women)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants undergo AI-enabled electrocardiography and focused cardiac ultrasound to evaluate heart disease.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
A
Amanda Priebe
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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