Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2026-02-01 @ 4:26 PM
Study NCT ID:
NCT06287892
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2023-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnosis of HCM With AI-ECG
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002312', 'term': 'Cardiomyopathy, Hypertrophic'}], 'ancestors': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001020', 'term': 'Aortic Stenosis, Subvalvular'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-04', 'studyFirstSubmitDate': '2023-04-08', 'studyFirstSubmitQcDate': '2024-02-29', 'lastUpdatePostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis of HCM with AI-ECG', 'timeFrame': '1 year within the time frame of ECG data collection', 'description': 'First a diagnosis of HCM is made as the standard outcome according to 1) an International Classification of Diseases (ICD) code for HCM (ICD-9425.1, 425.11, 425.18, and ICD10 I42.1, I42.2); 2) reports from the echocardiographers.\n\nAn AI-ECG algorithm will be used to make a diagnosis of HCM and compared with the standard outcome.\n\nThe performance of the AI-ECG algorithm will be evaluated with metrics including AU-ROC, specificity, sensitivity and F1 value.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertrophic Cardiomyopathy']}, 'descriptionModule': {'briefSummary': 'The study aims to establish a diagnostic model of hypertrophic cardiomyopathy with artificial intelligence-enhanced electrocardiogram.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study includes patients with HCM, and subjects without HCM as control.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with HCM\n\nExclusion Criteria:\n\n* Patients with ventricular pacing'}, 'identificationModule': {'nctId': 'NCT06287892', 'briefTitle': 'Diagnosis of HCM With AI-ECG', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Diagnosis of Hypertrophic Cardiomyopathy With Artificial Intelligence-enhanced Electrocardiogram', 'orgStudyIdInfo': {'id': 'AI-ECG-HCM'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HCM group', 'description': 'Patients diagnosed with HCM'}, {'label': 'Control group', 'description': 'Subjects without HCM'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yixiu Liang, MD', 'role': 'CONTACT', 'email': 'liang.yixiu@zs-hospital.sh.cn', 'phone': '+8664041990', 'phoneExt': '612844'}], 'facility': '180 Fenglin Road', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yixiu Liang, MD', 'role': 'CONTACT', 'email': 'liang.yixiu@zs-hospital.sh.cn', 'phone': '+8613764653847'}], 'overallOfficials': [{'name': 'Yixiu Liang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Department of Cardiology', 'investigatorFullName': 'Yixiu Liang', 'investigatorAffiliation': 'Shanghai Zhongshan Hospital'}}}}