Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT05933902
Status:
COMPLETED
Last Update Posted:
2023-07-06
First Post:
2023-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multicenter Retrospective Observational Study of Acute Myocarditis in Korea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-03', 'size': 165711, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-07-03T02:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 841}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-03', 'studyFirstSubmitDate': '2023-05-12', 'studyFirstSubmitQcDate': '2023-07-03', 'lastUpdatePostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of In hospital mortality', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'In hospital death by any cause'}], 'secondaryOutcomes': [{'measure': 'Rate of all-cause mortality', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Death by any cause during follow-up'}, {'measure': 'Requirement of cardiac replacement therapy', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Left ventricular assist device insertion or heart transplantation during follow-up'}, {'measure': 'Rates of Re-hospitalization due to any cause', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Re-hospitalization due to any cause during follow-up'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myocarditis Acute']}, 'referencesModule': {'references': [{'pmid': '40628676', 'type': 'DERIVED', 'citation': 'Hong D, Bak M, Park H, Kim HY, Lee S, Kim IC, Hyun J, Kim SR, Kim MN, Kim KH, Yang JH. Association Between Vasoactive Inotropic Score and Clinical Outcomes in Patients With Fulminant Myocarditis. Korean Circ J. 2025 Oct;55(10):938-951. doi: 10.4070/kcj.2024.0445. Epub 2025 May 28.'}, {'pmid': '39805629', 'type': 'DERIVED', 'citation': 'Hyun J, Pack D, Bak M, Park H, Kim HY, Lee S, Kim IC, Kim SR, Kim MN, Kim KH, Lee SE, Yang JH. Clinical Characteristics and Outcomes of Acute Myocarditis: An Analysis of Korean Multicenter Registry. Korean Circ J. 2025 May;55(5):410-422. doi: 10.4070/kcj.2024.0229. Epub 2024 Dec 10.'}, {'pmid': '38936469', 'type': 'DERIVED', 'citation': 'Bak M, Hyun J, Park H, Kim HY, Lee S, Kim IC, Kim SR, Kim MN, Kim KH, Yang JH. Early unloading and clinical outcomes in patients with fulminant myocarditis undergoing VA-ECMO: results of a multicenter retrospective study. Rev Esp Cardiol (Engl Ed). 2025 Mar;78(3):176-184. doi: 10.1016/j.rec.2024.06.004. Epub 2024 Jun 25. English, Spanish.'}]}, 'descriptionModule': {'briefSummary': 'In this study, the investigators analyze the clinical characteristics and prognosis of patients with acute myocarditis in South Korea', 'detailedDescription': 'Acute myocarditis refers to a condition in which inflammatory cells infiltrate the heart muscle due to various causes. Until now, there is no clear treatment method for myocarditis itself, and when myocardial function deteriorates or arrhythmia occurs due to myocarditis, it is common to wait for natural recovery while performing general supportive treatment for heart failure.\n\nThrough this study, the investigators analyze the factors contributing to the long-term prognosis, myocardial recovery rate, and clinical course of myocarditis. And, the investigators plan to establish an appropriate treatment strategy necessary to increase the survival rate of patients with myocarditis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with acute myocarditis at 6 domestic hospitals in South Korea from January 2004 to December 2021', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Typical myocarditis symptom and sign, such as fever, chest pain, chest discomfort or shortness of breath, accompanied by elevated myocardial enzymes\n* The above condition is satisfied and additional information is obtained through imaging such as cardiac MRI or cardiac biopsy\n\nExclusion Criteria:\n\n● Coronary artery disease'}, 'identificationModule': {'nctId': 'NCT05933902', 'briefTitle': 'Multicenter Retrospective Observational Study of Acute Myocarditis in Korea', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Multicenter Retrospective Observational Study to Investigate the Characteristics and Prognosis of Patients With Acute Myocarditis in Korea', 'orgStudyIdInfo': {'id': '2022-01-003-003'}}, 'contactsLocationsModule': {'locations': [{'zip': '06351', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jeong Hoon Yang', 'role': 'STUDY_CHAIR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chonnam National University Hospital', 'class': 'OTHER'}, {'name': 'Sejong General Hospital', 'class': 'OTHER'}, {'name': 'Keimyung University Dongsan Medical Center', 'class': 'OTHER'}, {'name': 'Korea University Anam Hospital', 'class': 'OTHER'}, {'name': 'Asan Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jeong Hoon Yang', 'investigatorAffiliation': 'Samsung Medical Center'}}}}