AI-algorithm UsagePAPPNCT07405866
A Prospective Analysis To Assess The Potential Use Of ECGio In Clinical Practice
An observational study of AI-algorithm Usage, run by Heart Input Output Inc at 4 sites in United States.
Trial summary
The goal of this observational study is to learn if an ai-assistive algorithm would be useful in patients who are under suspicion of coronary disease. The main question it aims to answer: What proportion of patients would clinicians see fit to order an ai-assistive algorithm if available for clinical use? Participants… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- AI-algorithm Usage
- What is being tested?
- AI-Assistive Algorithm
- Type of treatment
- Medical device
- How many people
- 10,000 participants
- Where
- 4 sitesUnited States
- Study dates
- 21 Feb 2026to 21 Nov 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: This study will be conducted in patients who fall within the guidelines for referral to calcium scoring and present at the Cardiology Consultant's of Philadelphia's Advanced Access Center, or present at one of their clinics for pre-operative screening.
Who may be able to join
- Age ≥ 18 years.
- Patients with medical records stored in a digitized format.
- Presenting between February 1 2026 and October 31 2026.
- Patient meets one of the following criteria:
- Hypertension
- Hyperlipidemia
Show all 11Show fewer
- Family History of Disease
- Diabetes Mellitus
- High BMI (>30)
- Smoker (Former or Current)
- Presenting for pre-operative clearance
Who cannot join
- Patients with acute coronary syndrome (ACS).
- Patient with prior Coronary Artery Bypass Grafting (CABG)
- Patients whose ECG tracing has extreme noise or artifact to the extent that it would be recommended to redo the tracing.
- Age ≥ 90 years.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Cardiology Consultants of Philadelphia - Rothman Orthopedics
Bensalem, Pennsylvania, 19020
Lisa Polli, 6102273627, lisap@ccpdocs.com
Cardiology Consultants of Philadelphia - Chestnus St
Philadelphia, Pennsylvania, 19107
Lisa Polli, 6102273627, lisap@ccpdocs.com
Cardiology Consultants of Philadelphia
Philadelphia, Pennsylvania, 19148
Lisa Polli, 6102273627, lisap@ccpdocs.com
Cardiology Consultants of Philadelphia - Sproul
Springfield, Pennsylvania, 19064
Lisa Polli, 6102273627, lisap@ccpdocs.com
About this study
The goal of this observational study is to learn if an ai-assistive algorithm would be useful in patients who are under suspicion of coronary disease. The main question it aims to answer:
What proportion of patients would clinicians see fit to order an ai-assistive algorithm if available for clinical use?
Participants will be asked to use clinical judgement as to whether a patient fits a predetermined criteria for use and select them for ai-assistive analysis.
Read the detailed description
An anonymous and de-identified database to be created over the next 9 months at the Cardiology Consultants of Philadelphia. Clinicians will be given the opportunity to select patients who would be appropriate for the analysis, then the study database will be able to be collected retrospectively after the fact. The second database will be a survey response database collected anonymously and de-identified of a simple random sample of clinicians (see 6.2) who "ordered" ECGio. The EMR will be scraped by CCP after the fact to identify which patients (whether ECGio was "ordered" or not) would be appropriate for ECGio usage based on the criteria defined in section 3.1.
Digital (or PDF), anonymous, and de-identified ECG tracings for the cohort will be collected from the MUSE system. We will be provided an example of the ECG tracing as an XML export (or other format acceptable to the study sponsor), lasting 10 seconds with 500 Hz sampling. Within the digital tracing a total of 5000 data points exist for each of 12 standard leads (aVL, I, -aVR, II, aVF, III, V1, V2, V3, V4, V5, and V6).
- Conditions
- AI-algorithm Usage
- Being tested
- AI-Assistive Algorithm
- Keywords
- Artificial Intelligence, Advanced Usage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Assistive AlgorithmDevice
Also called ECGio
ECGio is the first coronary stenosis detection software utilizing data from just a 10-second electrocardiogram (ECG). ECGs are inexpensive, non-invasive, commonly administered tests, and measure the electrical activity of the heart in "waves". The ECGio diagnostic algorithm is an ECG analytic tool which provides the clinician with information to detect the presence, severity, and location of clinically significant coronary artery disease. This diagnostic algorithm is currently not FDA approved, but once FDA approval is received, the labeling will address the following indication and use.
| Study group | Role | What they receive |
|---|---|---|
| AI-Assistive Algorithm Usage | This group is the patients who were selected as appropriate for use of the AI-Assistive algorithm. Receives: Device: AI-Assistive Algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usage Proportion
The proportion of patients in which it was deemed appropriate to use the AI-Assistive Algorithm
Measured: During or within 1 day, on average, of the patient visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start21 Feb 2026 (estimated)
- Primary completion21 Nov 2026 (estimated)
- Study completion21 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AI-algorithm UsageStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heart Input Output Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Veronica Covalesky, MD, Principal investigator, Cardiology Consultants of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07405866
- Sponsor's protocol ID
- HIO0007A
- Acronym
- PAPP
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Analysis To Assess The Potential Use Of ECGio In Clinical Practice
- ClinicalTrials.gov ID
- NCT07405866
- Acronym / sponsor ID
- PAPP / HIO0007A
- Conditions
- AI-algorithm Usage
- Keywords
- Artificial Intelligence, Advanced Usage
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Heart Input Output IncIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2026 (estimated)
- Primary completion
- 21 Nov 2026 (estimated)
- Study completion
- 21 Nov 2026 (estimated)
- First posted
- 12 Feb 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 goal of this observational study is to learn if an ai-assistive algorithm would be useful in patients who are under suspicion of coronary disease. The main question it aims to answer:
What proportion of patients would clinicians see fit to order an ai-assistive algorithm if available for clinical use?
Participants will be asked to use clinical judgement as to whether a patient fits a predetermined criteria for use and select them for ai-assistive analysis.
Detailed description
An anonymous and de-identified database to be created over the next 9 months at the Cardiology Consultants of Philadelphia. Clinicians will be given the opportunity to select patients who would be appropriate for the analysis, then the study database will be able to be collected retrospectively after the fact. The second database will be a survey response database collected anonymously and de-identified of a simple random sample of clinicians (see 6.2) who "ordered" ECGio. The EMR will be scraped by CCP after the fact to identify which patients (whether ECGio was "ordered" or not) would be appropriate for ECGio usage based on the criteria defined in section 3.1.
Digital (or PDF), anonymous, and de-identified ECG tracings for the cohort will be collected from the MUSE system. We will be provided an example of the ECG tracing as an XML export (or other format acceptable to the study sponsor), lasting 10 seconds with 500 Hz sampling. Within the digital tracing a total of 5000 data points exist for each of 12 standard leads (aVL, I, -aVR, II, aVF, III, V1, V2, V3, V4, V5, and V6).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AI-Assistive Algorithm Usage | – | Device: AI-Assistive AlgorithmThis group is the patients who were selected as appropriate for use of the AI-Assistive algorithm. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be conducted in patients who fall within the guidelines for referral to calcium scoring and present at the Cardiology Consultant's of Philadelphia's Advanced Access Center, or present at one of their clinics for pre-operative screening.
Key inclusion criteria (11 listed)
- Age ≥ 18 years.
- Patients with medical records stored in a digitized format.
- Presenting between February 1 2026 and October 31 2026.
- Patient meets one of the following criteria:
Key exclusion criteria (4 listed)
- Patients with acute coronary syndrome (ACS).
- Patient with prior Coronary Artery Bypass Grafting (CABG)
- Patients whose ECG tracing has extreme noise or artifact to the extent that it would be recommended to redo the tracing.
- Age ≥ 90 years.
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-Assistive AlgorithmAlso: ECGioECGio is the first coronary stenosis detection software utilizing data from just a 10-second electrocardiogram (ECG). ECGs are inexpensive, non-invasive, commonly administered tests, and measure the electrical activity of the heart in "waves". The ECGio diagnostic algorithm is an ECG analytic tool which provides the clinician with information to detect the presence, severity, and location of clinically significant coronary artery disease. This diagnostic algorithm is currently not FDA approved, but once FDA approval is received, the labeling will address the following indication and use. | Device | AI-Assistive Algorithm Usage |
Primary outcome
Usage Proportion
Time frame: During or within 1 day, on average, of the patient visit
The proportion of patients in which it was deemed appropriate to use the AI-Assistive Algorithm
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 12 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Veronica Covalesky, MD principal investigator
Cardiology Consultants of Philadelphia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AI-algorithm Usage, run by Heart Input Output Inc at 4 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 11 inclusion and 4 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 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Usage Proportion (time frame: During or within 1 day, on average, of the patient visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2026.