Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-03-08 @ 4:26 AM
Study NCT ID:
NCT06850233
Status:
COMPLETED
Last Update Posted:
2025-12-05
First Post:
2025-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Validation of a CAD Screening Algorithm Based on Facial Photos in Community Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-02-21', 'studyFirstSubmitQcDate': '2025-02-23', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of the algorithm', 'timeFrame': 'at the end of enrollment (6 months)', 'description': 'The sensitivity of the CAD screening algorithm assessed in the group'}, {'measure': 'Specificity of the algorithm', 'timeFrame': 'at the end of enrollment (6 months)', 'description': 'The specificity of the CAD screening algorithm assessed in the group'}], 'secondaryOutcomes': [{'measure': 'Discriminative capabilities', 'timeFrame': 'at the end of enrollment (6 months)', 'description': 'Area under receiver operating curve (AUC) of the algorithm assessed in the group'}, {'measure': 'Positive predictive value (PPV)', 'timeFrame': 'at the end of enrollment (6 months)', 'description': 'PPV of the CAD screening algorithm assessed in the group'}, {'measure': 'Negative predictive value (NPV)', 'timeFrame': 'at the end of enrollment (6 months)', 'description': 'NPV of the CAD screening algorithm assessed in the group'}, {'measure': 'Diagnostic accuracy rate', 'timeFrame': 'at the end of enrollment (6 months)', 'description': 'Diagnostic accuracy rate of the algorithm assessed in the group'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Artificial Intelligence'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of a coronary heart disease screening algorithm based on facial photos in community population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'community sample', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Community population with a pre-test probability greater than 5% for coronary artery disease\n\nExclusion Criteria:\n\n* Prior percutaneous coronary intervention (PCI)\n* Prior coronary artery bypass graft (CABG)\n* The history of heart failure\n* With artificially facial alteration (i.e. cosmetic surgery, facial trauma or make-up)\n* Other situations which make patients fail to be photographed'}, 'identificationModule': {'nctId': 'NCT06850233', 'briefTitle': 'The Validation of a CAD Screening Algorithm Based on Facial Photos in Community Population', 'organization': {'class': 'OTHER_GOV', 'fullName': 'China National Center for Cardiovascular Diseases'}, 'officialTitle': 'The Validation of a Coronary Artery Disease Screening Algorithm Based on Facial Photos in Community Population', 'orgStudyIdInfo': {'id': '2024-ZX050'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Algorithm external validation group', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Algorithm external validation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '466099', 'city': 'Zhoukou', 'state': 'Henan', 'country': 'China', 'facility': "People's Road Community Health Service Center", 'geoPoint': {'lat': 33.63333, 'lon': 114.63333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China National Center for Cardiovascular Diseases', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}