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NOT YET RECRUITING
NCT07405866

A Prospective Analysis To Assess The Potential Use Of ECGio In Clinical Practice

Sponsor: Heart Input Output Inc

View on ClinicalTrials.gov

Summary

The goal of this observational study is to learn if an ai-assistive algorithm would be useful in patients who are under suspicion of coronary disease. The main question it aims to answer: What proportion of patients would clinicians see fit to order an ai-assistive algorithm if available for clinical use? Participants will be asked to use clinical judgement as to whether a patient fits a predetermined criteria for use and select them for ai-assistive analysis.

Key Details

Gender

All

Age Range

18 Years - 89 Years

Study Type

OBSERVATIONAL

Enrollment

10000

Start Date

2026-02-21

Completion Date

2026-11-21

Last Updated

2026-02-12

Healthy Volunteers

No

Interventions

DEVICE

AI-Assistive Algorithm

ECGio is the first coronary stenosis detection software utilizing data from just a 10-second electrocardiogram (ECG). ECGs are inexpensive, non-invasive, commonly administered tests, and measure the electrical activity of the heart in "waves". The ECGio diagnostic algorithm is an ECG analytic tool which provides the clinician with information to detect the presence, severity, and location of clinically significant coronary artery disease. This diagnostic algorithm is currently not FDA approved, but once FDA approval is received, the labeling will address the following indication and use.

Locations (4)

Cardiology Consultants of Philadelphia - Rothman Orthopedics

Bensalem, Pennsylvania, United States

Cardiology Consultants of Philadelphia - Chestnus St

Philadelphia, Pennsylvania, United States

Cardiology Consultants of Philadelphia

Philadelphia, Pennsylvania, United States

Cardiology Consultants of Philadelphia - Sproul

Springfield, Pennsylvania, United States