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NCT Number: NCT06891222

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cardiac Disease Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AI-ECG (artificial intelligence-enabled electrocardiogram)

Diagnostic Test

Participants will undergo electrocardiogram analysis using AI-ECG during the baseline visit

Focus Screening (focused cardiac ultrasonography)

Diagnostic Test

Participants will undergo a focused cardiac ultrasound if the AI-ECG reflects a positive value

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Number of deaths

    Time frame: 1 year

    Number of deaths will include all-cause deaths.

  2. Number of adverse cardiovascular events

    Time frame: 1 year

    Number of adverse cardiovascular events includes systolic heart failure, rt failure hospitalization.

  3. 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%.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Acronym: SCAN

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 24, 2025
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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