A Study of Electrocardiogram and Focused Cardiac Ultrasound for Enhanced Cardiac Disease Screening (SCAN)

June 4, 2026 updated by: Gal Tsaban, Mayo Clinic

Integrating Electrocardiogram and Focused Cardiac Ultrasound for Enhanced Cardiac Disease Screening; Structural Cardiac Assessment With Networked AI-ECG & FOCUS (SCAN) Study

The purpose of this study is to evaluate and compare the effectiveness of active screening for SHD in asymptomatic outpatients referred for an ECG, using a combination of AI-ECG and FOCUS. Invites will be sent and participants enrolled electronically.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not 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.
Observational

Enrollment (Actual)

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.
2705

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 Contact Backup

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

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

Yes

Sampling Method

Probability Sample

Study Population

All subjects aged 18 or older without known congenital or acquired SHD scheduled to undergo an elective outpatient electrocardiogram

Description

Inclusion Criteria:

  • Adult patients (>18 years of age)
  • Echocardiogram is not clinically indicated

Exclusion Criteria:

  • Prior history of congenital or acquired SHD, as defined by the following

    1. Aortic Stenosis:
    2. Heart Failure
    3. Left Ventricular Dysfunction
    4. Cardiac Amyloidosis
    5. Hypertrophic Cardiomyopathy (HCM)
    6. Rheumatic Heart Disease
    7. Congenital Heart Disease
  • Recent (within last 12 months) echocardiogram
  • Scheduled clinically indicated future echocardiogram
  • Inability to provide informed consent to participate in the study

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Integrated pathway
Diagnostic test: AI-ECG (artificial intelligence-enabled electrocardiogram)
Participants will undergo electrocardiogram analysis using AI-ECG during the baseline visit
Diagnostic test: Focus Screening (focused cardiac ultrasonography)
Participants will undergo a focused cardiac ultrasound if the AI-ECG reflects a positive value
Standard of Care pathway

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 subjects to be diagnosed with SHD (structural heart disease)
Time Frame: Baseline, 6 months, 1 year
Percentage of subjects to be diagnosed with SHD will be determined by the number of subjects that have a positive SHD screening. Positive SHD screening is defined by any one of the following: decreased LVEF (left ventricular ejection fraction), cardiac amyloidosis, aortic stenosis, and hypertrophic cardiomyopathy.
Baseline, 6 months, 1 year
Positive predictive value (PPV)
Time Frame: Baseline, 6 months, 1 year
Positive predictive value (PPV) will be measured as a percentage. PPV will reflect the percentage of times that each screening pathway matches a formal echocardiogram diagnosis.
Baseline, 6 months, 1 year

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 deaths
Time Frame: 1 year
Number of deaths will include all-cause deaths.
1 year
Number of adverse cardiovascular events
Time Frame: 1 year
Number of adverse cardiovascular events includes systolic heart failure, rt failure hospitalization.
1 year
Percentage of subjects to be diagnosed with decreased LVEF (left ventricular ejection fraction)
Time Frame: Baseline, 6 months,1 year
Percentage of subjects to be diagnosed with decreased LVEF will be determined by the percentage of subjects to have a LVEF lower than 50%.
Baseline, 6 months,1 year
Percentage of subjects to be diagnosed with cardiac amyloidosis
Time Frame: Baseline, 6 months,1 year
Percentage of subjects to be diagnosed with cardiac amyloidosis will be determined by the number of subjects that have a positive AI-ECG or ultrasound. Cardiac amyloidosis is the buildup of protein in the heart muscle that affect the structure and function of the heart.
Baseline, 6 months,1 year
Percentage of subjects to be diagnosed with aortic stenosis
Time Frame: Baseline, 6 months,1 year
Percentage of subjects to be diagnosed with aortic stenosis will be determined by the number of subjects that have a positive AI-ECG or ultrasound. Aortic stenosis is the narrowing of the aortic value decreasing the blood flow from heart to the aorta.
Baseline, 6 months,1 year
Percentage of subjects to be diagnosed with hypertrophic cardiomyopathy
Time Frame: Baseline, 6 months,1 year
Percentage of subjects to be diagnosed with hypertrophic cardiomyopathy will be determined by the number of subjects that have a positive AI-ECG or ultrasound. Hypertrophic cardiomyopathy is the thickening of the heart muscle which leads to reduced blood flow.
Baseline, 6 months,1 year

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: Gal Tsaban, M.D., Ph.D., 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.
April 14, 2025

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.
November 1, 2026

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.
December 1, 2026

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).
March 18, 2025

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.
March 18, 2025

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.
March 24, 2025

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.
June 8, 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.
June 4, 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.
May 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.
  • 25-000609

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

product manufactured in and exported from the U.S.

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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