NCT07375810Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 978 (estimated)
- First submitted
- 21 Jan 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 1 Jul 2026
- Lead sponsor
- Heart Input Output Inc
- Diseases
- Coronary artery disease
- NCT number
- NCT07375810
What you commit to
- Study type: Observational
- Planned participants: 978
- From 1 Apr 2026 to the primary completion date, 1 Jul 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who previously underwent coronary artery bypass grafting.
- Patients with prior percutaneous coronary intervention resulting in stenting.
Other illness
- Patients with acute coronary syndrome.
Other
- Patients whose electrocardiogram tracing has extreme noise or artifact to the extent that it would be recommended to redo the tracing.
- Unanalyzable invasive coronary angiogram.
- Unanalyzable Coronary Computed Tomography Angiography.
- Unanalyzable electrocardiogram signal.
- Incomplete invasive coronary angiogram (e.g., only the right coronary artery was injected and visualized).
- Patient core lab analyzed Coronary Computed Tomography Angiography showed ≥ 50% blockage in any vessel but patient was not referred to invasive coronary angiogram.
Who the study is looking for
- 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.
Age in the registry: 18 years to 89 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cena Research Institute Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| MedStar Washington Hospital Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.