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

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Conditions studied: Coronary Artery Disease (CAD)

In brief

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.

Key facts

Study ID

NCT07375810

Run by

Heart Input Output Inc

People needed

978

Starts

2026-04-01

Expected to finish

2026-09-01

Last updated by the study team

2026-03-30

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You 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 may not qualify 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.

Where it is running

• Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Cena Research Institute — Houston, Texas, United States

Full record on ClinicalTrials.gov

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