Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT06060132
Status:
UNKNOWN
Last Update Posted:
2023-09-29
First Post:
2023-09-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Risk Analysis of Cardiotoxic Medication Use Due to Sodium Arsenite Chloride Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D066126', 'term': 'Cardiotoxicity'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077237', 'term': 'Arsenic Trioxide'}], 'ancestors': [{'id': 'D001152', 'term': 'Arsenicals'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-23', 'studyFirstSubmitDate': '2023-09-18', 'studyFirstSubmitQcDate': '2023-09-23', 'lastUpdatePostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'arrhythmia', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Electrocardiogram shows arrhythmia with marked QT prolongation'}, {'measure': 'adverse reaction', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'All cardiac-related adverse events in the course of the disease regimen'}, {'measure': 'troponin', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Troponin values'}, {'measure': 'Echocardiogram LVEF', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Echocardiogram LVEF values'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['arsenious acid', 'arsenic trioxide', 'cardiotoxicity'], 'conditions': ['Adverse Reaction', 'Cardiotoxicity', 'Evaluation Study']}, 'descriptionModule': {'briefSummary': 'To study the current status of cardiotoxicity of arsenious acid by analyzing the literature, monitoring data, and real-world applications, and to discuss risk factors and preventive and control measures.', 'detailedDescription': "Through the project study, the risk rate of cardiotoxicity caused by arsenious acid will be verified and evaluated, and a typical case analysis will be conducted to assess the risk and benefit ratio of clinical use of arsenious acid injection and to formulate preventive measures, so as to guide the holder of the marketing authorization to carry out in-depth safety studies and to ensure the public's safe use of the drug."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients using sodium arsenite chloride injection from January 1, 2012 to December 31, 2022 approximately 400 people.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* the period of consultation (for inpatients, according to the time of admission) is from January 1, 2012 to December 31, 2022\n* the patient used arsenite sodium chloride injection\n\nExclusion Criteria:\n\n* Patients with incomplete clinical information'}, 'identificationModule': {'nctId': 'NCT06060132', 'briefTitle': 'Risk Analysis of Cardiotoxic Medication Use Due to Sodium Arsenite Chloride Injection', 'organization': {'class': 'OTHER', 'fullName': 'Qianfoshan Hospital'}, 'officialTitle': 'Risk Analysis of Cardiotoxic Medication Use Due to Sodium Arsenite Chloride Injection', 'orgStudyIdInfo': {'id': 'YSS001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Sodium arsenite chloride injection', 'type': 'DRUG', 'otherNames': ['arsenic trioxide'], 'description': 'Patient use of arsenite sodium chloride injection'}]}, 'contactsLocationsModule': {'locations': [{'zip': '250014', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yi Han, doctorate', 'role': 'CONTACT', 'email': '15552565120@163.com', 'phone': '15552565120'}], 'facility': 'China', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '250014', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yi Han, doctorate', 'role': 'CONTACT', 'email': '15552565120@163.com', 'phone': '15552565120'}], 'facility': 'First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province )', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Yi Han, doctorate', 'role': 'CONTACT', 'email': '15552565120@163.com', 'phone': '15552565120'}], 'overallOfficials': [{'name': 'Yi Han, doctorate', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qianfoshan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qianfoshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor of pharmacy', 'investigatorFullName': 'Yi Han', 'investigatorAffiliation': 'Qianfoshan Hospital'}}}}