Trials / Not Yet Recruiting
Not Yet RecruitingNCT07375810
Analysis of ECGio to Predict Coronary Stenosis Against a Mixed Reference Standard
A Study to Measure Underlying Coronary Stenosis; a Retrospective, Multi-center Study to Measure Efficacy of ECGio Against Multiple Reference Standards
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 978 (estimated)
- Sponsor
- Heart Input Output Inc · Industry
- Sex
- All
- Age
- 18 Years – 89 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AI-ECG Analysis | The AI-Analysis done on the ECGs in a retrospective fashion |
Timeline
- Start date
- 2026-04-01
- Primary completion
- 2026-07-01
- Completion
- 2026-09-01
- First posted
- 2026-01-29
- Last updated
- 2026-03-30
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07375810. Inclusion in this directory is not an endorsement.