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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-89
SponsorHeart Input Output Inc

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • AI-ECG Analysis

Treatment groups

978 Participants
are divided into 3 treatment groups

Sponsors and collaborators