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NCT Number: NCT07405866

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

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.

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Key information

Conditions

AI-algorithm Usage

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiology Consultants of Philadelphia - Rothman Orthopedics, Bensalem, Pennsylvania, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AI-Assistive Algorithm

Device

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.

Other names: ECGio

Primary outcomes

Usage Proportion

Time frame: During or within 1 day, on average, of the patient visit

The proportion of patients in which it was deemed appropriate to use the AI-Assistive Algorithm

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Leasure

CONTACT

[email protected]

6104517343

Sponsors and collaborators

Lead sponsor

Heart Input Output Inc

Industry

Registry information

Acronym: PAPP

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Feb 12, 2026
Registry last updated: Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.