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

NCT07375810 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 978

Last updated 2026-03-30

No results posted yet for this study

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.

Conditions

  • Coronary Artery Disease (CAD)

Interventions

DEVICE

AI-ECG Analysis

The AI-Analysis done on the ECGs in a retrospective fashion

Sponsors & Collaborators

  • Heart Input Output Inc

    lead INDUSTRY

Principal Investigators

  • Gary S Mintz · CardioVascular Research Foundation

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2026-07-01
Completion
2026-09-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07375810 on ClinicalTrials.gov