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Clinical Trials in the USA / NCT07405866
Starting soon Observational

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

NCT07405866 · tracked via the Priya Life Science USA tracker
Sponsor
Heart Input Output Inc
Phase
Observational
Started
2026-02-21
Last updated
2026-02-12

Condition(s) studied

AI-algorithm Usage

Investigational drug(s) / intervention(s)

AI-Assistive Algorithm

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
89 Years
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years. * Patients with medical records stored in a digitized format. * Presenting between February 1 2026 and October 31 2026. * Patient meets one of the following criteria: * Hypertension * Hyperlipidemia * Family History of Disease * Diabetes Mellitus * High BMI (\>30) * Smoker (Former or Current) * Presenting for pre-operative clearance Exclusion Criteria: * Patients with acute coronary syndrome (ACS). * Patient with prior Coronary Artery Bypass Grafting (CABG) * Patients whose ECG tracing has extreme noise or artifact to the extent that it would be recommended to redo the tracing. * Age ≥ 90 years.

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Cardiology Consultants of Philadelphia - Rothman Orthopedics Bensalem Pennsylvania
Cardiology Consultants of Philadelphia - Chestnus St Philadelphia Pennsylvania
Cardiology Consultants of Philadelphia Philadelphia Pennsylvania
Cardiology Consultants of Philadelphia - Sproul Springfield Pennsylvania

More Heart Input Output Inc trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07405866 on ClinicalTrials.gov ↗ ← All trials in the USA