Coronary Artery Disease (CAD)SUMMERNCT07375810
Analysis of ECGio to Predict Coronary Stenosis Against a Mixed Reference Standard
An observational study of Coronary Artery Disease (CAD), run by Heart Input Output Inc at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Coronary Artery Disease (CAD)
- What is being tested?
- AI-ECG Analysis
- Type of treatment
- Medical device
- How many people
- 978 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2026to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Cena Research Institute
Houston, Texas, 77055
Asif Ali, MD, 713-464-4140, drasif@hccheart.com
Asif Ali, MD
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Hector Garcia, M.D, (202) 877-7000, Hector.M.GarciaGarcia@medstar.net
About this study
Official title: 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.
- Conditions
- Coronary Artery Disease (CAD)
- Being tested
- AI-ECG Analysis
- Keywords
- Artificial Intelligence, Electrocardiogram, Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-ECG AnalysisDevice
The AI-Analysis done on the ECGs in a retrospective fashion
| Study group | Role | What they receive |
|---|---|---|
| CT Angiogram | This is the Cohort which received only Computed Tomography Angiography as a part of the study Receives: Device: AI-ECG Analysis | |
| Invasive Angiography | This is the Cohort which received both Computed Tomography Angiography and Invasive Angiography as a part of the study Receives: Device: AI-ECG Analysis | |
| Enrollment Period 2 | This Cohort is the continuation of enrollment of invasive angiogram patients beyond the completion of the primary endpoint Receives: Device: AI-ECG Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity & Specificity
The lower 95% bound of ECGio's sensitivity and specificity in patients who underwent invasive angiography or computed tomography angiography (Co-primary endpoints)
Measured: Within 30 days of enrollment
Secondary outcomes (3)
Sensitivity & Specificity
The lower 95% bound of ECGio's sensitivity and specificity in patients who underwent invasive angiography (Co-secondary endpoints) in enrollment period 2
Measured: For the first 300 patients referred to invasive angiography through study completion, an average of 90 days
Demographic Performance
ECGio's predictive performance across different demographic groups (e.g Race, Sex, Risk Factors)
Measured: For patients in the 30 days following computed tomography angiography
Angiographic Stenosis Prediction
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)
Measured: For the first 300 patients referred to invasive angiography through study completion, an average of 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 978 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heart Input Output Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary S Mintz, Principal investigator, CardioVascular Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375810
- Sponsor's protocol ID
- HIO0004A
- Acronym
- SUMMER
- Status last verified
- Mar 2026
- First submitted
- 21 Jan 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This data cannot be shared due to individual site data retention policies
Publications
Leasure M, Jain U, Butchy A, Otten J, Covalesky VA, McCormick D, Mintz GS. Deep Learning Algorithm Predicts Angiographic Coronary Artery Disease in Stable Patients Using Only a Standard 12-Lead Electrocardiogram. Can J Cardiol. 2021 Nov;37(11):1715-1724. doi: 10.1016/j.cjca.2021.08.005. Epub 2021 Aug 20.
PubMed 34419615
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Measure Underlying Coronary Stenosis; a Retrospective, Multi-center Study to Measure Efficacy of ECGio Against Multiple Reference Standards
- ClinicalTrials.gov ID
- NCT07375810
- Acronym / sponsor ID
- SUMMER / HIO0004A
- Conditions
- Coronary Artery Disease (CAD)
- Keywords
- Artificial Intelligence, Electrocardiogram, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 978 participants (estimated)
- Lead sponsor
- Heart Input Output IncIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CT Angiogram | – | Device: AI-ECG AnalysisThis is the Cohort which received only Computed Tomography Angiography as a part of the study |
| Invasive Angiography | – | Device: AI-ECG AnalysisThis is the Cohort which received both Computed Tomography Angiography and Invasive Angiography as a part of the study |
| Enrollment Period 2 | – | Device: AI-ECG AnalysisThis Cohort is the continuation of enrollment of invasive angiogram patients beyond the completion of the primary endpoint |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-ECG AnalysisThe AI-Analysis done on the ECGs in a retrospective fashion | Device | CT Angiogram, Enrollment Period 2, Invasive Angiography |
Primary outcome
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)
3 secondary outcomes
Sensitivity & Specificity
Time frame: 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
Angiographic Stenosis Prediction
Time frame: For the first 300 patients referred to invasive angiography through study completion, an average of 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Background: PubMed 34419615Leasure M, Jain U, Butchy A, Otten J, Covalesky VA, McCormick D, Mintz GS. Deep Learning Algorithm Predicts Angiographic Coronary Artery Disease in Stable Patients Using Only a Standard 12-Lead Electrocardiogram. Can J Cardiol. 2021 Nov;37(11):1715-1724. doi: 10.1016/j.cjca.2021.08.005. Epub 2021 Aug 20.
- Individual participant dataSharing planned: No. This data cannot be shared due to individual site data retention policies
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gary S Mintz principal investigator
CardioVascular Research Foundation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease (CAD), run by Heart Input Output Inc at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Leasure (6104517343, Michael.Leasure@heartio.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity & Specificity (time frame: Within 30 days of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07375810, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.