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Study suspended due to logistical/personnel difficulties
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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.
Primary objective:
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
Secondary objectives:
Primary hypothesis:
Patients 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.
Prospective monocentric study with to 2 arms
Study arm: Cardiac surgery group, Control arm: Routine cardiology group Minimum of 100 patients included into the study arm
Inclusion criteria for the study arm:
Adult patients having cardiac surgery done under use of cardiopulmonary bypass
Data collection:
Past 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S | Active Comparator | Study arm: Cardiac surgery group |
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| C | Active Comparator | Routine cardiology group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myocardial biopsies with TRU CUT 14 Gauge needle | Procedure | Myocardial needle biopsy and right atrial appendectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of non-invasive myocarditis screening exams (cardiac magnetic resonance, ecg, history, inflammatory markers) with biopsy results | 2 years | |
| Prognostic value of virus prevalence for the postoperative course | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Udo P Sechtem, MD | Head of Cardiology, Robert Bosch Krankenhaus, Stuttgart, Germany | Study Chair |
| Ulrich FW Franke, MD | Head of Cardiovascular Surgery, Robert Bosch Krankenhaus, Stuttgart, Germany | Study Director |
| Reinhardt Kandolf, MD | Director of Institute of Molecular Pathology University Tuebingen, Germany | Study Director |
| Hannibal Baccouche, MD | Department of Cardiology, Robert Bosch Krankenhaus, Stuttgart, Germany | Principal Investigator |
| Hardy Baumbach, MD | Department of Cardiovascular Surgery, Robert Bosch Krankenhaus Stuttgart, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Bosch Krankenhaus, Auerbachstrasse 110 | Stuttgart | Baden-Wurttemberg | 70376 | Germany |
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| ID | Term |
|---|---|
| D009205 | Myocarditis |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Endomyocardial biopsies | Procedure | 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 |
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