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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07351656
Status
Recruiting
Apply to this trial

Conditions

  • Heart Disease

Eligibility Criteria

Sex
ALL
Age
15 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Focused Cardiac Ultrasound — DIAGNOSTIC_TEST
    Focused cardiac ultrasound will utilize sonography to evaluate specific cardiac conditions, such as ventricular function, pericardial effusion, and valvular abnormalities.
  • 6-Lead AI-ECG — DIAGNOSTIC_TEST
    A 6-lead ECG uses six electrodes placed on the chest and limbs to record the heart's electrical activity from multiple perspectives.
  • 12-Lead AI-ECG — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

Start date
Mar 9, 2026
Status verified
Apr 2026
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

Enrollment
19,300 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Community dwelling adults
  • Experimental: Pregnant women
  • Experimental: Adolescents and young adults

Primary Outcome Measure

Percentage of participants with positive AI-ECG findings confirmed by echocardiography (Adolescents and young adults) [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Amanda Priebe
[email protected]
507-422-6932
Paul Friedman, MD (PRINCIPAL_INVESTIGATOR)

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Mayo Clinic in Rochester· Rochester, MN

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