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

NCT07405866 | Not Yet Recruiting FDA Device

• 1 other identifier: HIO0007A
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

AI-algorithm Usage

Keywords

Artificial Intelligence; Advanced Usage

Outcome Measures

Primary Outcomes (1)

• Usage Proportion

  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

Study Arms (1)

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

Interventions

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.

Also known as: ECGio

AI-Assistive Algorithm Usage

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heart Input Output Inc: lead

Study Sites (4)

Cardiology Consultants of Philadelphia - Rothman Orthopedics

Bensalem, Pennsylvania, 19020, United States

Location

Cardiology Consultants of Philadelphia - Chestnus St

Philadelphia, Pennsylvania, 19107, United States

Location

Cardiology Consultants of Philadelphia

Philadelphia, Pennsylvania, 19148, United States

Location

Cardiology Consultants of Philadelphia - Sproul

Springfield, Pennsylvania, 19064, United States

Location

Study Officials

• Veronica Covalesky, MD

  Cardiology Consultants of Philadelphia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Leasure

CONTACT

6104517343; Michael.Leasure@heartio.ai

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 12, 2026
• Study Start: February 21, 2026
• Primary Completion (Estimated): November 21, 2026
• Study Completion (Estimated): November 21, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)