Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 6:42 AM
Study NCT ID:
NCT07405866
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-12
First Post:
2026-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Analysis To Assess The Potential Use Of ECGio In Clinical Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-21', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-11-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-05', 'studyFirstSubmitDate': '2026-02-05', 'studyFirstSubmitQcDate': '2026-02-05', 'lastUpdatePostDateStruct': {'date': '2026-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Usage Proportion', 'timeFrame': 'During or within 1 day, on average, of the patient visit', 'description': 'The proportion of patients in which it was deemed appropriate to use the AI-Assistive Algorithm'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Artificial Intelligence', 'Advanced Usage'], 'conditions': ['AI-algorithm Usage']}, 'descriptionModule': {'briefSummary': '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:\n\nWhat proportion of patients would clinicians see fit to order an ai-assistive algorithm if available for clinical use?\n\nParticipants 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.', 'detailedDescription': '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.\n\nDigital (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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "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.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Patients with medical records stored in a digitized format.\n* Presenting between February 1 2026 and October 31 2026.\n* Patient meets one of the following criteria:\n\n * Hypertension\n * Hyperlipidemia\n * Family History of Disease\n * Diabetes Mellitus\n * High BMI (\\>30)\n * Smoker (Former or Current)\n * Presenting for pre-operative clearance\n\nExclusion Criteria:\n\n* Patients with acute coronary syndrome (ACS).\n* Patient with prior Coronary Artery Bypass Grafting (CABG)\n* Patients whose ECG tracing has extreme noise or artifact to the extent that it would be recommended to redo the tracing.\n* Age ≥ 90 years.'}, 'identificationModule': {'nctId': 'NCT07405866', 'acronym': 'PAPP', 'briefTitle': 'A Prospective Analysis To Assess The Potential Use Of ECGio In Clinical Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'Heart Input Output Inc'}, 'officialTitle': 'A Prospective Analysis To Assess The Potential Use Of ECGio In Clinical Practice', 'orgStudyIdInfo': {'id': 'HIO0007A'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AI-Assistive Algorithm Usage', 'description': 'This group is the patients who were selected as appropriate for use of the AI-Assistive algorithm.', 'interventionNames': ['Device: AI-Assistive Algorithm']}], 'interventions': [{'name': 'AI-Assistive Algorithm', 'type': 'DEVICE', 'otherNames': ['ECGio'], 'description': '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.', 'armGroupLabels': ['AI-Assistive Algorithm Usage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19020', 'city': 'Bensalem', 'state': 'Pennsylvania', 'country': 'United States', 'contacts': [{'name': 'Lisa Polli', 'role': 'CONTACT', 'email': 'lisap@ccpdocs.com', 'phone': '6102273627'}], 'facility': 'Cardiology Consultants of Philadelphia - Rothman Orthopedics', 'geoPoint': {'lat': 40.10455, 'lon': -74.95128}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'contacts': [{'name': 'Lisa Polli', 'role': 'CONTACT', 'email': 'lisap@ccpdocs.com', 'phone': '6102273627'}], 'facility': 'Cardiology Consultants of Philadelphia - Chestnus St', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19148', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'contacts': [{'name': 'Lisa Polli', 'role': 'CONTACT', 'email': 'lisap@ccpdocs.com', 'phone': '6102273627'}], 'facility': 'Cardiology Consultants of Philadelphia', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19064', 'city': 'Springfield', 'state': 'Pennsylvania', 'country': 'United States', 'contacts': [{'name': 'Lisa Polli', 'role': 'CONTACT', 'email': 'lisap@ccpdocs.com', 'phone': '6102273627'}], 'facility': 'Cardiology Consultants of Philadelphia - Sproul', 'geoPoint': {'lat': 39.93067, 'lon': -75.32019}}], 'centralContacts': [{'name': 'Michael Leasure', 'role': 'CONTACT', 'email': 'Michael.Leasure@heartio.ai', 'phone': '6104517343'}], 'overallOfficials': [{'name': 'Veronica Covalesky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiology Consultants of Philadelphia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heart Input Output Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}