Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT05268458
Status:
UNKNOWN
Last Update Posted:
2022-03-07
First Post:
2022-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Myocarditis After SARS-CoV2-Vaccination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009205', 'term': 'Myocarditis'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-03', 'studyFirstSubmitDate': '2022-03-03', 'studyFirstSubmitQcDate': '2022-03-03', 'lastUpdatePostDateStruct': {'date': '2022-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Combined Primary Endpoint', 'timeFrame': '6 months', 'description': 'Death, Hospitalization, symptomatic Heart Failure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS CoV-19', 'Vaccination'], 'conditions': ['Myocarditis and Cardiomyopathy']}, 'referencesModule': {'references': [{'pmid': '37416926', 'type': 'DERIVED', 'citation': 'Schroth D, Garg R, Bocova X, Hansmann J, Haass M, Yan A, Fernando C, Chacko B, Oikonomou A, White J, Alhussein MM, Giusca S, Ochs A, Korosoglou G, Andre F, Friedrich MG, Ochs M. Predictors of persistent symptoms after mRNA SARS-CoV-2 vaccine-related myocarditis (myovacc registry). Front Cardiovasc Med. 2023 Jun 21;10:1204232. doi: 10.3389/fcvm.2023.1204232. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'Background The novel coronavirus disease 2019 (COVID-19) caused by an infection with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has rapidly become a global pandemic with more than 190.000.000 infections and 4.250.000 reported deaths worldwide.\n\nSARS-CoV-2 vaccination plays an important role in containing the pandemic and the possible adverse complications of COVID-19. Large clinical trials have proven the safety and efficacy of the vaccines currently in use. Systemic reactions usually were mild, self-limiting and could be observed more often in younger vaccine recipients. Cases of myocarditis after vaccination have been reported for various vaccines. The new vaccines for SARS-CoV-2 also seem to be affected by this adverse reactions. The pathophysiology is uncertain so far.\n\nAim Aim of this study is a systematic registration of myocarditis cases associated with SARS-CoV-2 vaccination which were diagnosed and/or treated in participating centers. The main goal of this study is the characterization of clinical manifestations and prognosis of the disease.\n\nStudy Design Patient history, laboratory tests and cardiovascular imaging data of patients with suspected SARS-CoV-2 - vaccine associated myocarditis are documented. Patients with clinical suspicion of troponin-positive myocarditis within 30 days after receiving SARS-CoV-2 vaccine without evidence for apparent other causes e.g. infectious or autoimmune etiology were included. Clinical follow-up data is acquired.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with SARS-CoV-2 Vaccine-associated Myocarditis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* SARS-CoV-2 Vaccine-associated Myocarditis (\\< 30 days after vaccination) confirmed by cardiac MRI without evidence of alternative etiology (infectious, auto-immune myocarditis).\n\nExclusion Criteria:\n\n* missing individual consent'}, 'identificationModule': {'nctId': 'NCT05268458', 'acronym': 'MYOVACC', 'briefTitle': 'Myocarditis After SARS-CoV2-Vaccination', 'organization': {'class': 'OTHER', 'fullName': 'Theresien Hospital Mannheim'}, 'officialTitle': 'Myocarditis After SARS-CoV2-Vaccination: An International Patient Registry on Clinical Manifestations and Outcomes', 'orgStudyIdInfo': {'id': 'TKH-032022-001'}}, 'contactsLocationsModule': {'locations': [{'zip': '65168', 'city': 'Mannheim', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Marco Ochs, MD', 'role': 'CONTACT', 'email': 'm.ochs@theresienkrankenhaus.de'}], 'facility': 'Theresienkrankenhaus', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}], 'centralContacts': [{'name': 'Marco Ochs, MD', 'role': 'CONTACT', 'email': 'm.ochs@theresienkrankenhaus.de', 'phone': '49621/424-4268'}], 'overallOfficials': [{'name': 'Marco Ochs, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Theresien Hospital Mannheim'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Theresien Hospital Mannheim', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital Heidelberg, GER', 'class': 'UNKNOWN'}, {'name': 'GRN Hospital Weinheim, GER', 'class': 'UNKNOWN'}, {'name': 'McGill University Health Care Montreal, CA', 'class': 'UNKNOWN'}, {'name': 'Foothills Medical Centre Calgary, CA', 'class': 'UNKNOWN'}, {'name': 'Sunnybrooks Research Institute Toronto, CA', 'class': 'UNKNOWN'}, {'name': "Unity Health St. Michael's Hospital Toronto, CA", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending, Cardiologist', 'investigatorFullName': 'Marco Ochs', 'investigatorAffiliation': 'Theresien Hospital Mannheim'}}}}