Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-01-01 @ 5:17 AM
Study NCT ID:
NCT06783933
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-14
First Post:
2025-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Artificial Intelligence-assisted Diagnosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2030-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-10', 'studyFirstSubmitDate': '2025-01-15', 'studyFirstSubmitQcDate': '2025-01-15', 'lastUpdatePostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'accuracy with AI-assisted diagnosis', 'timeFrame': '12 months', 'description': 'Number of subjects with accuracy of CHD ; based on surgical validation or interventional validation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['artificial intelligence；congenital heart diseases；Chest X-ray；diagnosis'], 'conditions': ['Congenital Heart Disease (CHD)', 'Structural Heart Disease']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate whether an AI-assisted decision support can improve the diagnosis of congenital heart diseases on Chest X-ray.', 'detailedDescription': 'Congenital heart disease (CHD) is a structural abnormality of the heart and/or great vessels and the frequency of CHD is nearly 1% in general population. In clinical practice, Chest X-ray is an important routine method for detection of CHD. However, its learning curve is high. Based on Chest X-ray, Artificial intelligence (AI) has the potential to improve the efficiency and accuracy of CHD. This study aims to investigate whether an AI-assisted decision support can improve the diagnosis of congenital heart diseases on Chest X-ray.\n\nThis study will enroll subjects with CHD, and the enrollment will be divided into two phases.\n\nPhase 1: Previous data of chest X-ray in patients with CHD. A minimum of 5000 patients is reached.\n\nPhase 2: Prospective inclusion of general patients with chest X-ray. A minimum of 50000 patients is reached.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study will enroll subjects with CHD and structural heart diseases.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Chest X-ray of patients with ASD;\n2. Chest X-ray of patients with VSD;\n3. Chest X-ray of patients with PDA;\n4. Chest X-ray of patients with PFO;\n5. Chest X-ray of patients with PS;\n6. Chest X-ray of patients with TOF/PAA;\n7. Chest X-ray of patients with MS;\n8. Chest X-ray of patients with other heart diseases;\n\nExclusion Criteria:\n\n1. CHD Patients without surgical, interventional validation;\n2. Serious Scoliosis;\n3. Pulmonary inflammation or consolidation'}, 'identificationModule': {'nctId': 'NCT06783933', 'acronym': 'AID', 'briefTitle': 'Artificial Intelligence-assisted Diagnosis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'China National Center for Cardiovascular Diseases'}, 'officialTitle': 'Artificial Intelligence-assisted Diagnosis of Congenital Heart Diseases on Chest X-ray', 'orgStudyIdInfo': {'id': '2020-4'}, 'secondaryIdInfos': [{'id': '2021YFF0501400', 'type': 'OTHER', 'domain': 'Ministry of Science and Technology'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Previous data of chest X-ray in patients with CHD', 'description': 'Phase 1: Previous data of chest X-ray in patients with CHD. A minimum of 5000 patients is reached.', 'interventionNames': ['Diagnostic Test: surgical or interventional validation']}, {'label': 'Prospective inclusion of general patients with chest X-ray', 'description': 'Prospective inclusion of general patients with chest X-ray. A minimum of 50000 patients is reached.', 'interventionNames': ['Diagnostic Test: surgical or interventional validation']}], 'interventions': [{'name': 'surgical or interventional validation', 'type': 'DIAGNOSTIC_TEST', 'description': 'surgical or interventional validation', 'armGroupLabels': ['Previous data of chest X-ray in patients with CHD', 'Prospective inclusion of general patients with chest X-ray']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100037', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Fuwai hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Shihua Zhao, MD and PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fuwai Hospital, Beijing, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data that support the findings of this study are available from the corresponding author upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China National Center for Cardiovascular Diseases', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Beijing Anzhen Hospital', 'class': 'OTHER'}, {'name': 'Nanjing Medical University', 'class': 'OTHER'}, {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, {'name': 'Capital Medical University', 'class': 'OTHER'}, {'name': 'Sichuan University', 'class': 'OTHER'}, {'name': 'Kunming Medical University', 'class': 'OTHER'}, {'name': 'Anhui Medical University', 'class': 'OTHER'}, {'name': 'Shandong University', 'class': 'OTHER'}, {'name': 'Zhejiang University', 'class': 'OTHER'}, {'name': 'Peking Union Medical College', 'class': 'OTHER'}, {'name': 'Harbin Medical University', 'class': 'OTHER'}, {'name': "Xi'an Jiaotong University", 'class': 'OTHER'}, {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, {'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'Wuhan University', 'class': 'OTHER'}, {'name': 'Central South University', 'class': 'OTHER'}, {'name': 'University of Chinese Academy of Sciences', 'class': 'UNKNOWN'}, {'name': 'The First Hospital of Hebei Medical University', 'class': 'OTHER'}, {'name': 'Handan First Hospital', 'class': 'OTHER'}, {'name': 'Second Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, {'name': 'Anyang Maternal and Child Health Care Center', 'class': 'UNKNOWN'}, {'name': 'Wenzhou Medical University', 'class': 'OTHER'}, {'name': 'Guangxi Medical University', 'class': 'OTHER'}, {'name': 'Xinjiang Medical University', 'class': 'OTHER'}, {'name': 'Chongqing General Hospital', 'class': 'OTHER'}, {'name': "Tibet Autonomous Region People's Hospital", 'class': 'OTHER'}, {'name': 'The Affiliated Hospital of Zunyi Medical College', 'class': 'UNKNOWN'}, {'name': 'Second Affiliated Hospital of Nanchang University', 'class': 'OTHER'}, {'name': 'Second Xiangya Hospital of Central South University', 'class': 'OTHER'}, {'name': 'Second Hospital of Shanxi Medical University', 'class': 'OTHER'}, {'name': 'Handan Central Hospital', 'class': 'OTHER'}, {'name': 'Affiliated First Hospital of Ningxia Medical University', 'class': 'UNKNOWN'}, {'name': 'Chinese Academy of Medical Sciences, Fuwai Hospital', 'class': 'OTHER'}, {'name': 'Xijing Hospital', 'class': 'OTHER'}, {'name': "Inner Mongolia People's Hospital", 'class': 'OTHER'}, {'name': 'Qinghai province cardiovascular and cerebrovascular disease specialist hospital', 'class': 'UNKNOWN'}, {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, {'name': 'China Medical University, China', 'class': 'OTHER'}, {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, {'name': 'Tianjin Medical University General Hospital', 'class': 'OTHER'}, {'name': 'Hainan General Hospital', 'class': 'OTHER'}, {'name': 'Fujian Medical University', 'class': 'OTHER'}, {'name': 'Lanzhou University Second Hospital', 'class': 'OTHER'}, {'name': 'Second Hospital of Jilin University', 'class': 'OTHER'}, {'name': 'Zunyi Medical College', 'class': 'OTHER'}, {'name': 'Ningxia Medical University', 'class': 'OTHER'}, {'name': 'LanZhou University', 'class': 'OTHER'}, {'name': 'Jilin University', 'class': 'OTHER'}, {'name': 'West China Hospital', 'class': 'OTHER'}, {'name': 'Peking University', 'class': 'OTHER'}, {'name': 'Fudan University', 'class': 'OTHER'}, {'name': 'Ruijin Hospital', 'class': 'OTHER'}, {'name': 'Zhengzhou University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}