NCT07351656

A Study Of Heart Disease Using AI-Enabled Electrocardiography And Focused Cardiac Ultrasound

Screening for Heart Disease Using AI-Enabled Electrocardiography and Focused Cardiac Ultrasound: the AI CVD Screen Study.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 19,300 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

A study to evaluate feasibility, diagnostic yield, accuracy, and actionable thresholds of POC, immediate-feedback AI-ECG + AI FoCUS screening for cardiac disease in well described community populations.

Conditions

• Heart Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Focused Cardiac Ultrasound	Focused cardiac ultrasound will utilize sonography to evaluate specific cardiac conditions, such as ventricular function, pericardial effusion, and valvular abnormalities.
DIAGNOSTIC_TEST	6-Lead AI-ECG	A 6-lead ECG uses six electrodes placed on the chest and limbs to record the heart's electrical activity from multiple perspectives.
DIAGNOSTIC_TEST	12-Lead AI-ECG	A standard 12-lead ECG consists of 12 leads: 6 limb leads and 6 chest (precordial) leads. These leads record the heart's electrical activity from different angles to provide a comprehensive assessment of cardiac function.

Timeline

• Start date: 2026-02-01
• Primary completion: 2028-02-01
• Completion: 2028-02-01
• First posted: 2026-01-20
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States