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NCT Number: NCT07375810

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

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.

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Key information

Conditions

Coronary Artery Disease (CAD) Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medstar Washington Hospital Center, Washington D.C., District of Columbia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

AI-ECG Analysis

Device

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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)

  3. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Leasure

CONTACT

[email protected]

6104517343

Sponsors and collaborators

Lead sponsor

Heart Input Output Inc

Industry

Registry information

Official study title

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

Acronym: SUMMER

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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