AI-ECG Analysis: The AI-Analysis done on the ECGs in a retrospective fashion
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
89 Years
Healthy volunteers
No
Inclusion Criteria:
1. Patients 18 years of age or older at time of data collection.
2. Patients with medical records stored in a digitized format.
3. 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.
Exclusion Criteria:
1. Patients with acute coronary syndrome.
2. Patients who previously underwent coronary artery bypass grafting.
3. Patients whose electrocardiogram tracing has extreme noise or artifact to the extent that it would be recommended to redo the tracing.
4. Patients with prior percutaneous coronary intervention resulting in stenting.
5. Unanalyzable invasive coronary angiogram.
6. Unanalyzable Coronary Computed Tomography Angiography.
7. Unanalyzable electrocardiogram signal.
8. Incomplete invasive coronary angiogram (e.g., only the right coronary artery was injected and visualized).
9. Patient core lab analyzed Coronary Computed Tomography Angiography showed ≥ 50% blockage in any vessel but patient was not referred to invasive coronary angiogram.
Primary outcome measure(s)
Sensitivity & Specificity — Within 30 days of enrollment The lower 95% bound of ECGio's sensitivity and specificity in patients who underwent invasive angiography or computed tomography angiography (Co-primary endpoints)
Trial sites (2)
Facility
City
Region
Status
Medstar Washington Hospital Center
Washington D.C.
District of Columbia
Cena Research Institute
Houston
Texas
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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