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

Conditions

• AI-algorithm Usage

Eligibility Criteria

Sex

ALL

Age

18 Years - 89 Years

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

Start date

Feb 21, 2026

Status verified

Feb 2026

Primary completion

Nov 21, 2026

Completion

Nov 21, 2026

Study Design

Enrollment

10,000 participants (estimated)

Arms

• Arm: AI-Assistive Algorithm Usage
  This group is the patients who were selected as appropriate for use of the AI-Assistive algorithm.

Primary Outcome Measure

Usage Proportion [ Time Frame: During or within 1 day, on average, of the patient visit ]

Central Contacts

• Michael Leasure
  6104517343
  [email protected]

Locations (4)

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