Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-02-10 @ 2:45 AM
Study NCT ID:
NCT00511160
Status:
TERMINATED
Last Update Posted:
2016-10-05
First Post:
2007-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiotropic Viruses in Cardiac Surgery Patients Without Clinical Evidence of Myocarditis or Myocarditic Sequelae
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'whyStopped': 'Study suspended due to logistical/personnel difficulties', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-04', 'studyFirstSubmitDate': '2007-08-02', 'studyFirstSubmitQcDate': '2007-08-02', 'lastUpdatePostDateStruct': {'date': '2016-10-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the prevalence of PVB19 and HHV6 virus genome in heart muscle biopsies of cardiac surgery patients without clinical evidence of myocarditis or myocarditic sequelae', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Correlation of non-invasive myocarditis screening exams (cardiac magnetic resonance, ecg, history, inflammatory markers) with biopsy results', 'timeFrame': '2 years'}, {'measure': 'Prognostic value of virus prevalence for the postoperative course', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['myocarditis', 'parvovirus B19 (PVB19)', 'human herpes virus 6 (HHV6)', 'cardiac magnetic resonance tomography (CMR)'], 'conditions': ['Myocarditis']}, 'descriptionModule': {'briefSummary': 'Myocarditis is mainly caused by cardiotropic viruses. In recent time viruses found in endomyocardial biopsies mainly consist of parvovirus B19 (PVB19) and human herpesvirus 6 (HHV6). A definite causal link between virus-genome detection of PVB19 and/or HHV6 (via pcr techniques)and cardiac inflammation and dysfunction is however still missing.\n\nPrimary objective:\n\nTo determine the prevalence of PVB19 and HHV6 virus genome in heart muscle biopsies of cardiac surgery patients without clinical evidence of myocarditis or myocarditic sequelae\n\nSecondary objectives:\n\n1. Correlation of non-invasive myocarditis screening exams (cardiac magnetic resonance, ecg, history, inflammatory markers) with biopsy results\n2. Prognostic value of virus prevalence for the postoperative course\n\nPrimary hypothesis:\n\nPatients without clinical evidence of myocarditis or myocarditic sequelae demonstrate to a significant lesser extent inflammatory activity and virus genome in their myocardium as compared to patients being clinical suspicious for myocarditis.', 'detailedDescription': 'Prospective monocentric study with to 2 arms\n\nStudy arm: Cardiac surgery group, Control arm: Routine cardiology group Minimum of 100 patients included into the study arm\n\nInclusion criteria for the study arm:\n\nAdult patients having cardiac surgery done under use of cardiopulmonary bypass\n\nData collection:\n\nPast medical history, ecg, prior cardiovascular imaging (echo, ventriculography), cardiac magnetic resonance imaging (CMR), serologic studies, work-up of endomyocardial biopsies (histology, molecular-pathology, follow-up CMR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cardiac surgery with cardiopulmonary bypass\n\nExclusion Criteria:\n\n* No ability to give informed consent\n* presence of so far accepted parvovirus/herpesvirus associated comorbidities\n* contraindications for magnetic resonance'}, 'identificationModule': {'nctId': 'NCT00511160', 'briefTitle': 'Cardiotropic Viruses in Cardiac Surgery Patients Without Clinical Evidence of Myocarditis or Myocarditic Sequelae', 'organization': {'class': 'OTHER', 'fullName': 'Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)'}, 'officialTitle': 'Prevalence of Cardiotropic Viruses in Cardiac Surgery Patients Without Clinical Evidence of Myocarditis or Myocarditic Sequelae', 'orgStudyIdInfo': {'id': 'RBK103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'S', 'description': 'Study arm: Cardiac surgery group', 'interventionNames': ['Procedure: Myocardial biopsies with TRU CUT 14 Gauge needle']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C', 'description': 'Routine cardiology group', 'interventionNames': ['Procedure: Endomyocardial biopsies']}], 'interventions': [{'name': 'Myocardial biopsies with TRU CUT 14 Gauge needle', 'type': 'PROCEDURE', 'otherNames': ['TRU CUT 14 Gauge needle'], 'description': 'Myocardial needle biopsy and right atrial appendectomy', 'armGroupLabels': ['S']}, {'name': 'Endomyocardial biopsies', 'type': 'PROCEDURE', 'description': 'The control arm C consists of routine-workup of patients with suspected myocarditis, independent of the study arm C, but with analogous screening methods and comparable biopsy sampling', 'armGroupLabels': ['C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70376', 'city': 'Stuttgart', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Robert Bosch Krankenhaus, Auerbachstrasse 110', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}], 'overallOfficials': [{'name': 'Udo P Sechtem, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Head of Cardiology, Robert Bosch Krankenhaus, Stuttgart, Germany'}, {'name': 'Ulrich FW Franke, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Head of Cardiovascular Surgery, Robert Bosch Krankenhaus, Stuttgart, Germany'}, {'name': 'Reinhardt Kandolf, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Director of Institute of Molecular Pathology University Tuebingen, Germany'}, {'name': 'Hannibal Baccouche, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Cardiology, Robert Bosch Krankenhaus, Stuttgart, Germany'}, {'name': 'Hardy Baumbach, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Cardiovascular Surgery, Robert Bosch Krankenhaus Stuttgart, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Udo Sechtem', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Udo Sechtem', 'investigatorFullName': 'Udo Sechtem', 'investigatorAffiliation': 'Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)'}}}}