Clinical trial NCT00511160: Cardiotropic Viruses in Cardiac Surgery Patients Without Clinical Evidence of Myocarditis or Myocarditic Sequelae
Official title: Prevalence of Cardiotropic Viruses in Cardiac Surgery Patients Without Clinical Evidence of Myocarditis or Myocarditic Sequelae
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Myocarditis
Keywords: myocarditis
parvovirus B19 (PVB19)
human herpes virus 6 (HHV6)
cardiac magnetic resonance tomography (CMR)
Lead sponsor: Robert Bosch Gesellschaft für Medizinische Forschung mbH
Sponsor class: OTHER
First posted: 2007-08-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
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
Secondary outcomes:
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
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Robert Bosch Krankenhaus, Auerbachstrasse 110
state: Baden-Wuerttemberg
Study officials:
affiliation: Head of Cardiology, Robert Bosch Krankenhaus, Stuttgart, Germany
name: Udo P Sechtem, MD
role: STUDY_CHAIR
affiliation: Head of Cardiovascular Surgery, Robert Bosch Krankenhaus, Stuttgart, Germany
name: Ulrich FW Franke, MD
role: STUDY_DIRECTOR
affiliation: Director of Institute of Molecular Pathology University Tuebingen, Germany
name: Reinhardt Kandolf, MD
role: STUDY_DIRECTOR
affiliation: Department of Cardiology, Robert Bosch Krankenhaus, Stuttgart, Germany
name: Hannibal Baccouche, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiovascular Surgery, Robert Bosch Krankenhaus Stuttgart, Germany
name: Hardy Baumbach, MD
role: PRINCIPAL_INVESTIGATOR
References: