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

Recruiting

• Conditions: Cardiac Disease

• Registration Number: NCT06891222
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-18
• Study First Submitted QC: 2025-03-18
• Study First Posted: 2025-03-24
• Study Start: 2025-04-14
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of subjects to be diagnosed with SHD (structural heart disease)	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.
Positive predictive value (PPV)	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 Outcome Measures

Name	Time	Method
Number of deaths	1 year	Number of deaths will include all-cause deaths.
Number of adverse cardiovascular events	1 year	Number of adverse cardiovascular events includes systolic heart failure, rt failure hospitalization.
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 decreased LVEF will be determined by the percentage of subjects to have a LVEF lower than 50%.
Percentage of subjects to be diagnosed with cardiac amyloidosis	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.
Percentage of subjects to be diagnosed with aortic stenosis	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.
Percentage of subjects to be diagnosed with hypertrophic cardiomyopathy	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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States