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Starting soon Observational

Analysis of ECGio to Predict Coronary Stenosis Against a Mixed Reference Standard

NCT07375810 · tracked via the Priya Life Science USA tracker
Sponsor
Heart Input Output Inc
Phase
Observational
Started
2026-04-01
Last updated
2026-03-30

Condition(s) studied

Coronary Artery Disease (CAD)

Investigational drug(s) / intervention(s)

AI-ECG Analysis

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)

FacilityCityRegionStatus
Medstar Washington Hospital Center Washington D.C. District of Columbia
Cena Research Institute Houston Texas

More Heart Input Output Inc trials in the USA

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.

View NCT07375810 on ClinicalTrials.gov ↗ ← All trials in the USA