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

NCT07351656 | Recruiting

• 1 other identifier: 25-012252
• Study Type: interventional
• Target: 19,300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Disease

Outcome Measures

Primary Outcomes (3)

• Percentage of participants with positive AI-ECG findings confirmed by echocardiography (Adolescents and young adults)

  The percentage will be calculated as the number of participants whose AI-ECG results indicate a positive finding and are subsequently confirmed by echocardiography, divided by the total number of participants assessed, multiplied by 100.

  Baseline

• Number of patients with positive AI-ECG detection for left-right sided SHD (Community Dwelling Adults)

  Number of patients with positive AI-ECG detection for left-right sided SHD, defined as any of the following: LVEF \<50%, \>moderate right ventricular systolic dysfunction, \>moderate aortic, mitral, or tricuspid valve regurgitation or stenosis, pulmonary hypertension (right ventricular systolic pressure \> 50 mmHg), or elevated left-sided filling pressure.

  Baseline

• Number of times the AI-ECG provides a correct diagnosis of clinically significant cardiac disease (Pregnant women)

  Diagnostic performance of the AI-ECG will be determined by the accurate diagnosis of cardiomyopathy (left ventricular ejection fraction \[LVEF\] ≤50% or 10% or more decline in LVEF) or clinically significant structural heart disease (SHD; ≥ moderate right ventricular systolic dysfunction, ≥ moderate aortic, mitral, or tricuspid valve regurgitation or stenosis, pulmonary hypertension \[right ventricular systolic pressure \> 50 mmHg\], or myocardial disease such as hypertrophic cardiomyopathy) in pregnant patients and those up to 6 weeks postpartum compared to standard of care.

  Baseline

Secondary Outcomes (9)

• Number of false positive AI-ECG Results (Adolescents and young adults)

  Baseline

• Number of positive AI-ECG results for hypertrophic cardiomyopathy (HCM) (Adolescents and young adults)

  Baseline

• Number of positive AI-ECG results for congenital heart defect (CHD) (Adolescents and young adults)

  Baseline

• Proportion of patients by age group to receive a diagnosis (Community Dwelling Adults)

  Baseline

• Proportion of total patients to receive a diagnosis based on screening with 6 lead ECG (Community Dwelling Adults)

  Baseline

Study Arms (3)

Community dwelling adults

EXPERIMENTAL

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

Pregnant women

EXPERIMENTAL

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

Adolescents and young adults

EXPERIMENTAL

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

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.

Adolescents and young adults; Community dwelling adults; Pregnant women

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.

Adolescents and young adults; Community dwelling adults; Pregnant women

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.

Adolescents and young adults; Community dwelling adults; Pregnant women

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Presence of a pacemaker or defibrillator
• Inability to obtain a quality ECG tracing
• Community dwelling adults:
• Adult patients (\>30 years of age, with pre-specified subgroups 30-64 and 65+))
• Inability to provide informed consent to participate in the study
• Pregnant women:
• 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
• Inability to provide consent

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Paul Friedman, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Priebe

CONTACT

507-422-6932; Priebe.Amanda@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 10, 2026
• First Posted: January 20, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: May 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)