NCT07405866

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Heart Input Output Inc · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Detailed description

An anonymous and de-identified database to be created over the next 9 months at the Cardiology Consultants of Philadelphia. Clinicians will be given the opportunity to select patients who would be appropriate for the analysis, then the study database will be able to be collected retrospectively after the fact. The second database will be a survey response database collected anonymously and de-identified of a simple random sample of clinicians (see 6.2) who "ordered" ECGio. The EMR will be scraped by CCP after the fact to identify which patients (whether ECGio was "ordered" or not) would be appropriate for ECGio usage based on the criteria defined in section 3.1. Digital (or PDF), anonymous, and de-identified ECG tracings for the cohort will be collected from the MUSE system. We will be provided an example of the ECG tracing as an XML export (or other format acceptable to the study sponsor), lasting 10 seconds with 500 Hz sampling. Within the digital tracing a total of 5000 data points exist for each of 12 standard leads (aVL, I, -aVR, II, aVF, III, V1, V2, V3, V4, V5, and V6).

Conditions

• AI-algorithm Usage

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-21
• Primary completion: 2026-11-21
• Completion: 2026-11-21
• First posted: 2026-02-12
• Last updated: 2026-02-12

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study