Analysis of ECGio to Predict Coronary Stenosis Against a Mixed Reference Standard. (SUPER)

Heart Input Output Inc

Status: Not yet enrolling

Conditions: Coronary Artery Disease (CAD)

Study type: Observational

Funder types: Industry

Identifiers

NCT07375810

HIO004A

Details and patient eligibility

About

The study objective is to evaluate the effectiveness of the ECGio algorithm in predicting clinically significant coronary artery disease (CAD). ECGio's diagnostic performance during the trial will be compared against an objective performance ¬criteria (OPC) using a mixed reference standard of quantitative coronary angiography (QCA) and quantitative coronary computed tomography angiography (QCCTA) in patients a general adult population under suspicion of coronary artery disease.

Enrollment: 978 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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 CAD (both suspicion of significant CAD as well as to rule out significant CAD) who present to the site with an ECG recorded up to 30 days prior to Coronary Computed Tomography Angiography (CCTA).

Exclusion criteria

1. Patients with acute coronary syndrome (ACS).
2. Patients who previously underwent coronary artery bypass grafting (CABG).
3. Patients whose ECG 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 ICA.
6. Unanalyzable CCTA.
7. Unanalyzable ECG signal.
8. Incomplete ICA (e.g., only the right coronary artery was injected and visualized).
9. Patient core lab analyzed CTA showed ≥ 50% in any vessel but patient was not referred to ICA.

Trial design

978 participants in 3 patient groups

CT Angiogram

Description:

This is the Cohort which received only CT Angiogram as a part of the study

Invasive Angiography

Description:

This is the Cohort which received both CT Angiogram and Invasive Angiography as a part of the study

Enrollment Period 2

Description:

This Cohort is the continuation of enrollment of invasive angiogram patients beyond the completion of the primary endpoint