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

August 18, 2026 updated by: Paul A. Friedman, Mayo Clinic

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
        • Principal Investigator:
          • Paul Friedman, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • 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 18-29 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of participants with positive AI-ECG findings confirmed by echocardiography (Adolescents and young adults)
Time Frame: Baseline
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)
Time Frame: Baseline
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)
Time Frame: Baseline
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of false positive AI-ECG Results (Adolescents and young adults)
Time Frame: Baseline
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)
Time Frame: Baseline
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)
Time Frame: Baseline
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)
Time Frame: Baseline
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)
Time Frame: Baseline
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)
Time Frame: Baseline
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)
Time Frame: Baseline
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)
Time Frame: Baseline
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)
Time Frame: Baseline
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Paul Friedman, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 9, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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