What this study is
The study objective is to evaluate the effectiveness of the ECGio algorithm in predicting clinically significant coronary artery disease . ECGio's diagnostic performance during the trial will be compared against an objective performance ¬criteria using a mixed reference standard of quantitative coronary angiography and quantitative coronary computed tomography angiography in patients a general adult population under suspicion of coronary artery disease.
What's being tested
- AI-ECG Analysis
Intervention · DEVICE
The AI-Analysis done on the ECGs in a retrospective fashion
Study details
- Official title
- A Study to Measure Underlying Coronary Stenosis; a Retrospective, Multi-center Study to Measure Efficacy of ECGio Against Multiple Reference Standards
- Sponsor
- Heart Input Output Inc
- Conditions
- Coronary Artery Disease (CAD)
- Enrolling
- 978 people
- Starts
- 2026-04-01
- Est. completion
- 2026-09-01
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 89 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Patients 18 years of age or older at time of data collection.
- Patients with medical records stored in a digitized format.
- Patients under suspicion of coronary artery disease (both suspicion of significant coronary artery disease as well as to rule out significant CAD) who present to the site with an electrocardiogram recorded up to 30 days prior to Coronary Computed Tomography Angiography.
You can't join if
- Patients with acute coronary syndrome.
- Patients who previously underwent coronary artery bypass grafting.
- Patients whose electrocardiogram tracing has extreme noise or artifact to the extent that it would be recommended to redo the tracing.
- Patients with prior percutaneous coronary intervention resulting in stenting.
- Unanalyzable invasive coronary angiogram.
- Unanalyzable Coronary Computed Tomography Angiography.
- Unanalyzable electrocardiogram signal.
- Incomplete invasive coronary angiogram (e.g., only the right coronary artery was injected and visualized).
- Patient core lab analyzed Coronary Computed Tomography Angiography showed ≥ 50% blockage in any vessel but patient was not referred to invasive coronary angiogram.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openMedstar Washington Hospital Center
Washington D.C., District of Columbia, United States
- Hector Garcia, M.D · Contact(202) 877-7000Hector.M.GarciaGarcia@medstar.net
Cena Research Institute
Houston, Texas, United States
- Asif Ali, MD · Contact713-464-4140drasif@hccheart.com
- Asif Ali, MD · Principal investigator
Study team
Sponsor
Heart Input Output Inc
Study ID HIO0004A
Principal investigator
Gary S Mintz
CardioVascular Research Foundation
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.