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

February 5, 2026 updated by: Heart Input Output Inc

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Bensalem, Pennsylvania, United States, 19020
        • Cardiology Consultants of Philadelphia - Rothman Orthopedics
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19148
        • Cardiology Consultants of Philadelphia
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19107
        • Cardiology Consultants of Philadelphia - Chestnus St
        • Contact:
      • Springfield, Pennsylvania, United States, 19064
        • Cardiology Consultants of Philadelphia - Sproul
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study will be conducted in patients who fall within the guidelines for referral to calcium scoring and present at the Cardiology Consultant's of Philadelphia's Advanced Access Center, or present at one of their clinics for pre-operative screening.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AI-Assistive Algorithm Usage
This group is the patients who were selected as appropriate for use of the AI-Assistive algorithm.
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.
Other Names:
  • ECGio

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During or within 1 day, on average, of the patient visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart Input Output Inc

Investigators

  • Principal Investigator: Veronica Covalesky, MD, Cardiology Consultants of Philadelphia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 21, 2026

Primary Completion (Estimated)

November 21, 2026

Study Completion (Estimated)

November 21, 2026

Study Registration Dates

First Submitted

February 5, 2026

First Submitted That Met QC Criteria

February 5, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HIO0007A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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