NCT06891222 A Study of Electrocardiogram and Focused Cardiac Ultrasound for Enhanced Cardiac Disease Screening
| NCT ID | NCT06891222 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Cardiac Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,500 participants |
| Start Date | 2025-04-14 |
| Primary Completion | 2026-04 |
Trial Parameters
Eligibility Fast-Check
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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.
Eligibility Criteria
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