Myocarditis Clinical Trial
Official title:
Prevalence of Cardiotropic Viruses in Cardiac Surgery Patients Without Clinical Evidence of Myocarditis or Myocarditic Sequelae
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:
1. Correlation of non-invasive myocarditis screening exams (cardiac magnetic resonance,
ecg, history, inflammatory markers) with biopsy results
2. Prognostic value of virus prevalence for the postoperative course
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science
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