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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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Vanderbilt University Medical Center