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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-14

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiac Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Integrated pathway

AI-ECG (artificial intelligence-enabled electrocardiogram)

Intervention Type DIAGNOSTIC_TEST

Participants will undergo electrocardiogram analysis using AI-ECG during the baseline visit

Focus Screening (focused cardiac ultrasonography)

Intervention Type DIAGNOSTIC_TEST

Participants will undergo a focused cardiac ultrasound if the AI-ECG reflects a positive value

Standard of Care pathway

No interventions assigned to this group

Interventions

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AI-ECG (artificial intelligence-enabled electrocardiogram)

Participants will undergo electrocardiogram analysis using AI-ECG during the baseline visit

Intervention Type DIAGNOSTIC_TEST

Focus Screening (focused cardiac ultrasonography)

Participants will undergo a focused cardiac ultrasound if the AI-ECG reflects a positive value

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes