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

May 6, 2025 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

10500

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 Backup

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Gal Tsaban, MD, PhD

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

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
Intervention / Treatment
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

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

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

Mayo Clinic

Investigators

  • 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)

April 14, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

March 18, 2025

First Submitted That Met QC Criteria

March 18, 2025

First Posted (Actual)

March 24, 2025

Study Record Updates

Last Update Posted (Actual)

May 9, 2025

Last Update Submitted That Met QC Criteria

May 6, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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