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

Mayo Clinic

Status: Enrolling

Conditions: Cardiac Disease

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

Study type: Observational

Funder types: Other

Identifiers

NCT06891222

25-000609

Details and patient eligibility

About

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.

Enrollment: 10,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

10,500 participants in 2 patient groups

Integrated pathway

Treatment:

Diagnostic Test: AI-ECG (artificial intelligence-enabled electrocardiogram)

Diagnostic Test: Focus Screening (focused cardiac ultrasonography)

Standard of Care pathway