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

Purpose

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.

Condition

  • Cardiac Disease

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Mayo Clinic
Rochester, Minnesota 55905
Contact:
Gal Tsaban, MD, PhD
507-284-2129
Tsaban.Gal@mayo.edu

More Details

NCT ID
NCT06891222
Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

Catalina Paraschiv, M.D., Ph.D.
507-293-3800
Paraschiv.Catalina@mayo.edu