Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT00221832
Status:
UNKNOWN
Last Update Posted:
2010-01-13
First Post:
2005-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Molecular Genetic Screening and Identification of Congenital Arrhythmogenic Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008133', 'term': 'Long QT Syndrome'}, {'id': 'D002312', 'term': 'Cardiomyopathy, Hypertrophic'}, {'id': 'D019571', 'term': 'Arrhythmogenic Right Ventricular Dysplasia'}, {'id': 'C580439', 'term': 'Short Qt Syndrome'}, {'id': 'D053840', 'term': 'Brugada Syndrome'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D001020', 'term': 'Aortic Stenosis, Subvalvular'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'no biospecimens are to be retained.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2003-10', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-01-12', 'studyFirstSubmitDate': '2005-09-14', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2010-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Long QT Syndrome', 'Hypertrophic cardiomyopathy', 'arrhythmogenic right ventricular dysplasia', 'Short QT Syndrome', 'Brugada Syndrome'], 'conditions': ['Long QT Syndrome', 'Hypertrophic Cardiomyopathy', 'Arrhythmogenic Right Ventricular Dysplasia']}, 'descriptionModule': {'briefSummary': 'The aim of this study is the identification of familial congenital arrhythmogenic disorders and their clinical follow-up.', 'detailedDescription': 'Molecular genetic screening in patients with:\n\n* supraventricular\n* ventricular arrhythmia\n* syncopes of unknown origin and/or suspicion of an arrhythmogenic origin\n* family members of patients with sudden cardiac death and aborted sudden cardiac death\n\nExamination of patients includes routine testing like electrocardiogram (ECG), sequential ECGs, exercise testing, invasive electrophysiological stimulation, cardiac magnetic resonance imaging, intravenous drug challenge for identification/exclusion of eg Brugada syndrome. Examples are patients with Long QT Syndrome, Short QT Syndrome, Brugada Syndrome, familial atrial fibrillation, WPW-syndrome, arrhythmias due to familial hypertrophic cardiomyopathy or arrhythmogenic right ventricular dysplasia. Blood samples are taken for further molecular genetic screening.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patient sampling with history of syncope, aborted SCD, familial sudden cardiac death, high suspicion of familial cardiac arrhythmias.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a history of syncope, abnormal ECG and suspicion of an arrhythmogenic disease\n* Patients with long QT syndrome\n* Patients with short QT syndrome, shortened QT intervals, borderline shortened QT intervals\n* Patients with Brugada syndrome\n* Patients with hypertrophic cardiomyopathy\n* Patients with arrhythmogenic right ventricular dysplasia\n\nExclusion Criteria:\n\n* Inability to understand study protocol'}, 'identificationModule': {'nctId': 'NCT00221832', 'briefTitle': 'Molecular Genetic Screening and Identification of Congenital Arrhythmogenic Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Molecular Genetic Screening and Identification of Congenital Arrhythmogenic Diseases', 'orgStudyIdInfo': {'id': '0261.5'}}, 'contactsLocationsModule': {'locations': [{'zip': '68167', 'city': 'Mannheim', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christian Wolpert, MD', 'role': 'CONTACT', 'email': 'christian.wolpert@med.ma.uni-heidelberg.de', 'phone': '+49-621-3832206'}, {'name': 'Rainer Schimpf, MD', 'role': 'CONTACT', 'email': 'rainer.schimpf@med.ma.uni-heidelberg.de', 'phone': '+49-621-3832206'}, {'name': 'Christian Wolpert, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Mannheim, I. Department of Medicine', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}], 'centralContacts': [{'name': 'Christian Wolpert, MD', 'role': 'CONTACT', 'email': 'christian.wolpert@med.ma.uni-heidelberg.de', 'phone': '+49-621-383-2206'}, {'name': 'Rainer Schimpf, MD', 'role': 'CONTACT', 'email': 'rainer.schimpf@med.ma.uni-heidelberg.de', 'phone': '+49-621-383-2206'}], 'overallOfficials': [{'name': 'Martin Borggrefe, Prof., MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'I. Department of Medicine-Cardiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. C. Wolpert, I. Department of Medicine-Cardiology, University Hospital Mannheim', 'oldOrganization': '. Department of Medicine-Cardiology, University Hospital Mannheim'}}}}