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ClinicalTrials.gov ID

NCT07375810

Lead Sponsor

Heart Input Output IncINDUSTRY

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

978Estimated

Last Update Posted

Mar 30, 2026Actual

Start Date

Apr 1, 2026Estimated

Primary Completion Date

Jul 1, 2026Estimated

Completion Date

Sep 1, 2026Estimated

Official Title

A Study to Measure Underlying Coronary Stenosis; a Retrospective, Multi-center Study to Measure Efficacy of ECGio Against Multiple Reference Standards

Brief 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.

• Coronary Artery Disease (CAD)

• AI-ECG Analysis

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Observational Model

Cohort

Time Perspective

Retrospective

Lead Sponsor

Heart Input Output IncINDUSTRY

drasif@hccheart.com713-464-4140