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

NCT06891222 | Active Not Recruiting

• 1 other identifier: 25-000609
• Study Type: observational
• Target: 2,705
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Disease

Outcome Measures

Primary Outcomes (2)

• Percentage of subjects to be diagnosed with SHD (structural heart disease)

  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)

  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 Outcomes (6)

• Number of deaths

  1 year

• Number of adverse cardiovascular events

  1 year

• Percentage of subjects to be diagnosed with decreased LVEF (left ventricular ejection fraction)

  Baseline, 6 months,1 year

• Percentage of subjects to be diagnosed with cardiac amyloidosis

  Baseline, 6 months,1 year

• Percentage of subjects to be diagnosed with aortic stenosis

  Baseline, 6 months,1 year

Study Arms (2)

Integrated pathway

Diagnostic Test: AI-ECG (artificial intelligence-enabled electrocardiogram); Diagnostic Test: Focus Screening (focused cardiac ultrasonography)

Standard of Care pathway

Interventions

AI-ECG (artificial intelligence-enabled electrocardiogram) DIAGNOSTIC_TEST

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

Integrated pathway

Focus Screening (focused cardiac ultrasonography) DIAGNOSTIC_TEST

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

Integrated pathway

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Gal Tsaban, M.D., Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 24, 2025
• Study Start: April 14, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)