Cardiotropic Viruses in Cardiac Surgery Patients Without Clinical Evidence of Myocarditis or Myocarditic Sequelae

Study Overview
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Brief Summary
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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: Correlation of non-invasive myocarditis screening exams (cardiac magnetic resonance, ecg, history, inflammatory markers) with biopsy results 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.

Detailed Description
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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.

Official Title
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Prevalence of Cardiotropic Viruses in Cardiac Surgery Patients Without Clinical Evidence of Myocarditis or Myocarditic Sequelae

Conditions
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Myocarditis

Intervention / Treatment
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* Procedure: Myocardial biopsies with TRU CUT 14 Gauge needle
* Procedure: Endomyocardial biopsies


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cardiac surgery with cardiopulmonary bypass Exclusion Criteria: No ability to give informed consent presence of so far accepted parvovirus/herpesvirus associated comorbidities contraindications for magnetic resonance

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: S<br>Study arm: Cardiac surgery group | Procedure: Myocardial biopsies with TRU CUT 14 Gauge needle<br>* Myocardial needle biopsy and right atrial appendectomy<br>* Other names: TRU CUT 14 Gauge needle;|
| Active Comparator: C<br>Routine cardiology group | Procedure: Endomyocardial biopsies<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myocarditis, parvovirus B19 (PVB19), human herpes virus 6 (HHV6), cardiac magnetic resonance tomography (CMR)