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.

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Disease
• Intervention / Treatment: Diagnostic test: Focused Cardiac Ultrasound; Diagnostic test: 6-Lead AI-ECG; Diagnostic test: 12-Lead AI-ECG

• Study Type: Interventional
• Enrollment (Estimated): 19300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amanda Priebe; Phone Number: 507-422-6932; Email: Priebe.Amanda@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Amanda Priebe; Phone Number: 507-422-6932; Email: Priebe.Amanda@mayo.edu
      • Principal Investigator: Paul Friedman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pregnant women	Diagnostic test: Focused Cardiac Ultrasound; Focused cardiac ultrasound will utilize sonography to evaluate specific cardiac conditions, such as ventricular function, pericardial effusion, and valvular abnormalities.; Diagnostic test: 6-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 test: 12-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.
Experimental: Community dwelling adults	Diagnostic test: Focused Cardiac Ultrasound; Focused cardiac ultrasound will utilize sonography to evaluate specific cardiac conditions, such as ventricular function, pericardial effusion, and valvular abnormalities.; Diagnostic test: 6-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 test: 12-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.
Experimental: Adolescents and young adults	Diagnostic test: Focused Cardiac Ultrasound; Focused cardiac ultrasound will utilize sonography to evaluate specific cardiac conditions, such as ventricular function, pericardial effusion, and valvular abnormalities.; Diagnostic test: 6-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 test: 12-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of false positive AI-ECG Results (Adolescents and young adults)	Number of false positive AI-ECG results will be determined by the number of positive AI-ECG results proven false from an echocardiography	Baseline
Number of positive AI-ECG results for hypertrophic cardiomyopathy (HCM) (Adolescents and young adults)	The number of positive AI-ECG results for HCM will be based on how many patient ECGs indicate a possible diagnosis of HCM	Baseline
Number of positive AI-ECG results for congenital heart defect (CHD) (Adolescents and young adults)	The number of positive AI-ECG results for CHD will be based on how many patient ECGs indicate a possible diagnosis of CHD	Baseline
Proportion of patients by age group to receive a diagnosis (Community Dwelling Adults)	Proportion of patients by age group (30-39, 40-49, 50-65, 65-74, and 75 years and older) to receive a diagnosis from ultrasound that is confirmed by a comprehensive diagnostic work up.	Baseline
Proportion of total patients to receive a diagnosis based on screening with 6 lead ECG (Community Dwelling Adults)	Proportion of total patients to receive a diagnosis based on screening with 6 lead ECG will be determined by the number of patients to have a correct diagnosis using the 6 lead ECG confirmed by echocardiogram compared to the total number of patients.	Baseline
Proportion of total patients to receive a diagnosis based on screening with 12 lead ECG (Community Dwelling Adults)	Proportion of total patients to receive a diagnosis based on screening with 12 lead ECG will be determined by the number of patients to have a correct diagnosis using the 12 lead ECG confirmed by echocardiogram compared to the total number of patients.	Baseline
Proportion of total patients to receive a diagnosis based on screening with 12 lead only AI-ECG with adjunctive FoCUS (Community Dwelling Adults)	Proportion of total patients to receive a diagnosis based on screening with 12 lead only AI-ECG with adjunctive FoCUS will be determined by the number of patients to have a correct diagnosis using the 12 lead ECG with adjunctive FoCUS confirmed by standard of care echocardiogram compared to the total number of patients.	Baseline
Proportion of total patients to receive a diagnosis based on screening with 12 lead only AI-ECG without adjunctive FoCUS (Community Dwelling Adults)	Proportion of total patients to receive a diagnosis based on screening with 12 lead only AI-ECG without adjunctive FoCUS will be determined by the number of patients to have a correct diagnosis using the 12 lead ECG without adjunctive FoCUS confirmed by standard of care echocardiogram compared to the total number of patients.	Baseline
Number of non-cardiac adverse events (Pregnant Women)	Number of non-cardiac adverse events can include hypertensive disorders of pregnancy (gestational hypertension, pre-eclampsia, eclampsia), preterm delivery, gestational diabetes, small for gestational age delivery, placental abruption, and pregnancy loss.	Baseline

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Paul Friedman, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: January 10, 2026
• First Submitted That Met QC Criteria: January 10, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: 25-012252

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No