RecruitingNot ApplicableNCT07351656

A Study Of Heart Disease Using AI-Enabled Electrocardiography And Focused Cardiac Ultrasound

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


Sponsor

Mayo Clinic

Enrollment

19,300 participants

Start Date

Mar 9, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

A study to evaluate feasibility, diagnostic yield, accuracy, and actionable thresholds of POC, immediate-feedback AI-ECG + AI FoCUS screening for cardiac disease in well described community populations.


Eligibility

Min Age: 15 Years

Inclusion Criteria9

  • Adolescents and young adults:
  • Enrollment in a high-school, college or a resident in MN during the study period
  • Age 15-29 years
  • Informed consent (and assent for minors)
  • Adult patients (>30 years of age, with pre-specified subgroups 30-64 and 65+))
  • 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 Criteria6

  • Presence of a pacemaker or defibrillator
  • Inability to obtain a quality ECG tracing
  • Community dwelling adults:
  • Inability to provide informed consent to participate in the study
  • Pregnant women:
  • Inability to provide consent

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Interventions

DIAGNOSTIC_TESTFocused Cardiac Ultrasound

Focused cardiac ultrasound will utilize sonography to evaluate specific cardiac conditions, such as ventricular function, pericardial effusion, and valvular abnormalities.

DIAGNOSTIC_TEST6-Lead AI-ECG

A 6-lead ECG uses six electrodes placed on the chest and limbs to record the heart's electrical activity from multiple perspectives.

DIAGNOSTIC_TEST12-Lead AI-ECG

A standard 12-lead ECG consists of 12 leads: 6 limb leads and 6 chest (precordial) leads. These leads record the heart's electrical activity from different angles to provide a comprehensive assessment of cardiac function.


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT07351656


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