Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT06447935
Status:
COMPLETED
Last Update Posted:
2024-06-07
First Post:
2024-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acute Eosinophilic Myocarditis International Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009205', 'term': 'Myocarditis'}], 'ancestors': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-05-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-03', 'studyFirstSubmitDate': '2024-05-28', 'studyFirstSubmitQcDate': '2024-06-03', 'lastUpdatePostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Natural History of Eosinophilic Myocarditis', 'timeFrame': '3 year', 'description': 'Proportion of patients who die or need a heart transplantation from index admission.'}], 'secondaryOutcomes': [{'measure': 'Natural History of Eosinophilic Myocarditis subgroups based on etiology', 'timeFrame': '3 years', 'description': 'Proportion of patients who die or need a heart transplantation from index admission dividing patients based on the underlying condition (for instance idiopathic, hypersensitivity, eosinophilic granulomatosis with polyangiitis,…)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Eosinophilic Myocarditis', 'Endomyocardial Biopsy'], 'conditions': ['Myocarditis']}, 'descriptionModule': {'briefSummary': 'Retrospective collection of clinical, histological, imaging data regarding patients with acute histologically-proven eosinophilic myocarditis.', 'detailedDescription': 'Eosinophilic myocarditis (EM) is an acute life-threatening inflammatory disease of the heart. We collect clinical, histologic, laboratory, diagnostic and imaging data regarding acute EM with a histological diagnosis and symptoms onset within 30 days from first medical contact from hospitals around the world. The main objective is to investigate and describe clinical presentation, main systemic conditions associated and outcomes of the first series of patients with acute myocarditis and histological evidence of eosinophilic infiltration within myocardium.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A retrospective observational cohort of eosinophilic myocarditis patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patients with histological diagnosis gained during an hospitalization within 30 days from symptoms onset.'}, 'identificationModule': {'nctId': 'NCT06447935', 'briefTitle': 'Acute Eosinophilic Myocarditis International Registry', 'organization': {'class': 'OTHER', 'fullName': 'Niguarda Hospital'}, 'officialTitle': 'Acute Eosinophilic Myocarditis International Registry', 'orgStudyIdInfo': {'id': 'NIGUARDA H'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute Eosinophilic Myocarditis', 'description': 'Patients affected by Acute Eosinophilic Myocarditis with the following inclusion criteria:\n\n1. histologically EM proven "borderline" (presence of inflammatory infiltrate) or "active" (presence of inflammatory infiltrate plus myocardial necrosis) myocarditis, according to the Dallas criteria;\n2. acute presentation defined by the onset of cardiac symptoms within 30 days before admission.', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'not applicable - no intervention required', 'armGroupLabels': ['Acute Eosinophilic Myocarditis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20162', 'city': 'Milan', 'country': 'Italy', 'facility': 'ASST GOM Niguarda', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Niguarda Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}