Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT06009718
Status:
RECRUITING
Last Update Posted:
2025-01-16
First Post:
2023-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Artificial Intelligence (AI) Analysis of Synchronized Phonocardiography (PCG) and Electrocardiogram(ECG)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2028-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-14', 'studyFirstSubmitDate': '2023-07-06', 'studyFirstSubmitQcDate': '2023-08-19', 'lastUpdatePostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of Heart Failure Disease', 'timeFrame': 'one time assessment at baseline (approx. 5 minutes)', 'description': 'Heart Failure Disease was determined by EMAT （millisecond, ms）calculate from synchronized PCG and ECG signals using an artificial intelligence (AI) guided model.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Phonocardiography (PCG)', 'Electrocardiogram (ECG)', 'Heart Failure (HF)', 'depressed left ventricular ejection fraction (dLVEF)'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The diagnosis of depressed left ventricular ejection fraction (dLVEF) (EF\\<50%) depends on golden standard ultrasound cardiography (UCG). A wearable synchronized phonocardiography (PCG) and electrocardiogram (ECG) device can assist in the diagnosis of dLVEF, which can both expedite access to life-saving therapies and reduce the need for costly testing.', 'detailedDescription': 'The synchronized PCG and ECG is wirelessly paired with the WenXin Mobile application, allowing for simultaneous recording and visualization of PCG and ECG. These features uniquely enable this device to accumulate large sets of acoustic data on patients both with and without heart failure(HF).\n\nThis study is a Case-control study. In this study, the investigators seek to develop an artificial intelligence (AI) analysis system to identify dLVEF (EF\\<50%) by PCG and ECG. All adults (aged ≥18 years) planned for UCG were eligible to participate (inpatients and outpatients). Specifically, the investigators will attempt to develop machine learning algorithms to learn synchronized PCG and ECG of patients with dLVEF. Then we use these algorithms to identify dLVEF subjects. The investigators anticipate to demonstrate the wearable cardiac patch with synchronized PCG and ECG can reliably and accurately diagnose dLVEF in the primary care setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This is one-center cohort study. Patients undergo echocardiogram at Ruijin Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Attendance at RuiJin hospital for UCG\n* Signed dated informed consent\n* Commit to follow the research procedures and cooperate in the implementation of the whole process research\n* UCG has been completed\n* Age ≥ 18\n* At least 8 consecutive cycles of sinus rhythm can be recorded\n\nExclusion Criteria:\n\n* Patients with pacemakers\n* Complete left bundle branch block or block or QRS wave widening\\>120ms\n* Left chest skin damaged or allergic to patch\n* Refusal to participate'}, 'identificationModule': {'nctId': 'NCT06009718', 'briefTitle': 'Artificial Intelligence (AI) Analysis of Synchronized Phonocardiography (PCG) and Electrocardiogram(ECG)', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'A Deep-learning-based Multi-modal Phonocardiogram(PCG) and Electrocardiogram(ECG) Processing Framework for Screening Depressed Left Ventricular Ejection Fraction (dLVEF) Using a Wearable Cardiac Patch', 'orgStudyIdInfo': {'id': 'RJH-PEG'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Model training group', 'description': 'Compare the results of PCG and ECG with UCG, and conduct model training analysis'}, {'label': 'Model validation group', 'description': 'Compare the results of PCG and ECG with UCG, and conduct model validation analysis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenli Zhang, MD', 'role': 'CONTACT', 'email': '13917615339@163.com', 'phone': '+86 021 64370045'}, {'name': 'Ruiyan Zhang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Wenli Zhang, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ruijin Hospital, Shanghai Jiaotong School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200030', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jingjuan Huang, MD，PhD', 'role': 'CONTACT', 'email': 'hjjxinhua@163.com', 'phone': '+86 021 22200000'}, {'name': 'Ruogu Li, MD，PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jingjuan Huang, MD，PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Shanghai Chest Hospital, Shanghai Jiao Tong University School Of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200123', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Chen, MD', 'role': 'CONTACT', 'email': '1427926201@qq.com', 'phone': '+86 15900727844'}, {'name': 'Min Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shanghai East Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Wenli Zhang, MD', 'role': 'CONTACT', 'email': 'zwl11929@rjh.com.cn', 'phone': '+86 21 13917615339'}, {'name': 'Bei Song, MD', 'role': 'CONTACT', 'email': 'belasong@163.com', 'phone': '+86 21 15821960139'}], 'overallOfficials': [{'name': 'Ruiyan Zhang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital, Shanghai Jiaotong School of Medicine'}, {'name': 'Wenli Zhang, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ruijin Hospital, Shanghai Jiaotong School of Medicine'}, {'name': 'Bei Song, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ruijin Hospital, Shanghai Jiaotong School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Cardiology Department, Chief Physician', 'investigatorFullName': 'RUIYAN ZHANG', 'investigatorAffiliation': 'Ruijin Hospital'}}}}