Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-03-01 @ 9:58 AM
Study NCT ID:
NCT05048602
Status:
UNKNOWN
Last Update Posted:
2021-09-17
First Post:
2021-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug-induced Brugada Syndrome Research Database
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053840', 'term': 'Brugada Syndrome'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2025-09-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-08', 'studyFirstSubmitDate': '2021-09-08', 'studyFirstSubmitQcDate': '2021-09-08', 'lastUpdatePostDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sudden Cardiac Death', 'timeFrame': '1 year', 'description': 'Unexpected death due to cardiac causes that occurs in a short time period.'}, {'measure': 'Appropriate ICD Therapies', 'timeFrame': '1 year', 'description': 'Antitachycardia pacing therapy or shock delivered by ICD for device detected ventricular arrhythmia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brugada Syndrome', 'Arrhythmia', 'ICD']}, 'descriptionModule': {'briefSummary': 'All patients with drug-induced Brugada syndrome who are evaluated and followed at each participating centers will be recorded in this register. Within this register a characterization of patients and therapy will be done. Prognostic factors of adefined clinical relevant endpoints will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with drug-induced Brudaga Syndrome', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All consecutive patients with drug-induced Brugada Syndrome\n\nExclusion Criteria:\n\n* Missing Informed Consent Form\n* Missing Contact Informations for Follow up'}, 'identificationModule': {'nctId': 'NCT05048602', 'briefTitle': 'Drug-induced Brugada Syndrome Research Database', 'organization': {'class': 'OTHER', 'fullName': 'University of Campania Luigi Vanvitelli'}, 'officialTitle': 'Drug-induced Brugada Syndrome Research Database', 'orgStudyIdInfo': {'id': '07082021'}}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Naples', 'state': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Vincenzo Russo', 'role': 'CONTACT', 'email': 'vincenzo.russo@unicampania.it'}], 'facility': 'Vincenzo Russo', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}], 'centralContacts': [{'name': 'Vincenzo Russo, MD PhD', 'role': 'CONTACT', 'email': 'vincenzo.russo@unicampania.it', 'phone': '+390817062355'}], 'overallOfficials': [{'name': 'Vincenzo Russo, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Campania Luigi Vanvitelli'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Campania Luigi Vanvitelli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Vincenzo Russo', 'investigatorAffiliation': 'University of Campania Luigi Vanvitelli'}}}}