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

Mayo Clinic

Status: Not yet enrolling

Conditions: Heart Disease

Treatments: Diagnostic Test: 12-Lead AI-ECG; Diagnostic Test: Focused Cardiac Ultrasound; Diagnostic Test: 6-Lead AI-ECG

Study type: Interventional

Funder types: Other

Identifiers

NCT07351656

25-012252

Details and patient eligibility

About

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.

Enrollment: 19,300 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Adolescents and young adults:

Inclusion Criteria:

• 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)

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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19,300 participants in 3 patient groups

Community dwelling adults

Experimental group

Treatment:

Diagnostic Test: 6-Lead AI-ECG

Diagnostic Test: Focused Cardiac Ultrasound

Diagnostic Test: 12-Lead AI-ECG

Pregnant women

Experimental group

Treatment:

Diagnostic Test: 6-Lead AI-ECG

Diagnostic Test: Focused Cardiac Ultrasound

Diagnostic Test: 12-Lead AI-ECG

Adolescents and young adults

Experimental group

Treatment:

Diagnostic Test: 6-Lead AI-ECG

Diagnostic Test: Focused Cardiac Ultrasound

Diagnostic Test: 12-Lead AI-ECG