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

March 25, 2026 updated by: Heart Input Output Inc

A Study to Measure Underlying Coronary Stenosis; a Retrospective, Multi-center Study to Measure Efficacy of ECGio Against Multiple Reference Standards

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

978

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
    • Texas
      • Houston, Texas, United States, 77055
        • Cena Research Institute
        • Contact:
        • Principal Investigator:
          • Asif Ali, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will be made up of all-comers to Coronary Computed Tomography Angiography from each site taking up to the first 250, consecutive patients recruited for the analysis.

Description

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 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.

Exclusion Criteria:

  1. Patients with acute coronary syndrome.
  2. Patients who previously underwent coronary artery bypass grafting.
  3. Patients whose electrocardiogram 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 invasive coronary angiogram.
  6. Unanalyzable Coronary Computed Tomography Angiography.
  7. Unanalyzable electrocardiogram signal.
  8. Incomplete invasive coronary angiogram (e.g., only the right coronary artery was injected and visualized).
  9. Patient core lab analyzed Coronary Computed Tomography Angiography showed ≥ 50% blockage in any vessel but patient was not referred to invasive coronary angiogram.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Enrollment Period 2
This Cohort is the continuation of enrollment of invasive angiogram patients beyond the completion of the primary endpoint
Device: AI-ECG Analysis
The AI-Analysis done on the ECGs in a retrospective fashion
CT Angiogram
This is the Cohort which received only Computed Tomography Angiography as a part of the study
Device: AI-ECG Analysis
The AI-Analysis done on the ECGs in a retrospective fashion
Invasive Angiography
This is the Cohort which received both Computed Tomography Angiography and Invasive Angiography as a part of the study
Device: AI-ECG Analysis
The AI-Analysis done on the ECGs in a retrospective fashion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity & Specificity
Time Frame: Within 30 days of enrollment
The lower 95% bound of ECGio's sensitivity and specificity in patients who underwent invasive angiography or computed tomography angiography (Co-primary endpoints)
Within 30 days of enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity & Specificity
Time Frame: For the first 300 patients referred to invasive angiography through study completion, an average of 90 days
The lower 95% bound of ECGio's sensitivity and specificity in patients who underwent invasive angiography (Co-secondary endpoints) in enrollment period 2
For the first 300 patients referred to invasive angiography through study completion, an average of 90 days
Demographic Performance
Time Frame: For patients in the 30 days following computed tomography angiography
ECGio's predictive performance across different demographic groups (e.g Race, Sex, Risk Factors)
For patients in the 30 days following computed tomography angiography
Angiographic Stenosis Prediction
Time Frame: For the first 300 patients referred to invasive angiography through study completion, an average of 90 days
The Root Mean Squared Error in predicting the greatest diameter stenosis per vessel (Left Main Artery, Left Anterior Descending Artery, Left Circumflex Artery, Right Coronary Artery)
For the first 300 patients referred to invasive angiography through study completion, an average of 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart Input Output Inc

Investigators

  • Principal Investigator: Gary S Mintz, CardioVascular Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIO0004A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This data cannot be shared due to individual site data retention policies

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease (CAD)

Clinical Trials on AI-ECG Analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe