A Prospective Analysis To Assess The Potential Use Of ECGio In Clinical Practice
Heart Input Output Inc
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.
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 app…
Eligibility
- Age range
- 18–89 years
- Sex
- All
- Healthy volunteers
- No
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 w…
Interventions
- DeviceAI-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.
Locations (4)
- Cardiology Consultants of Philadelphia - Rothman OrthopedicsBensalem, Pennsylvania
- Cardiology Consultants of Philadelphia - Chestnus StPhiladelphia, Pennsylvania
- Cardiology Consultants of PhiladelphiaPhiladelphia, Pennsylvania
- Cardiology Consultants of Philadelphia - SproulSpringfield, Pennsylvania