A Prospective Analysis To Assess The Potential Use Of ECGio In Clinical Practice
ConditionAI-algorithm Usage
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-89
SponsorHeart Input Output Inc
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years.
Patients with medical records stored in a digitized format.
Presenting between February 1 2026 and October 31 2026.
Hypertension
Disqualifiers
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.
Trial 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
AI-Assistive Algorithm
DeviceECGio 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.
Treatment groups
10,000 Participants
are divided into 1 treatment groupGroup A: AI-Assistive Algorithm Usage1 intervention
Trial outcomes
Primary outcomes
1
Usage Proportion
The proportion of patients in which it was deemed appropriate to use the AI-Assistive Algorithm
Time frame
During or within 1 day, on average, of the patient visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: