Not Yet RecruitingNot Applicable

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

United States978 participantsStarted 2026-04-01

Plain-language 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.

Who can participate

Age range18 Years – 89 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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).

What they're measuring

Sensitivity & Specificity

Timeframe: Within 30 days of enrollment

Trial details

NCT IDNCT07375810

SponsorHeart Input Output Inc

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-07-01

Contact for this trial

Michael Leasure

6104517343 Michael.Leasure@heartio.ai

View on ClinicalTrials.gov More Coronary Artery Disease (CAD) trials