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

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.

Conditions

• Myocarditis

Interventions

PROCEDURE

Myocardial biopsies with TRU CUT 14 Gauge needle

Myocardial needle biopsy and right atrial appendectomy

PROCEDURE

Endomyocardial biopsies

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

Sponsors & Collaborators

• Udo Sechtem

  lead OTHER

Principal Investigators

• Udo P Sechtem, MD · Head of Cardiology, Robert Bosch Krankenhaus, Stuttgart, Germany

• Ulrich FW Franke, MD · Head of Cardiovascular Surgery, Robert Bosch Krankenhaus, Stuttgart, Germany

• Reinhardt Kandolf, MD · Director of Institute of Molecular Pathology University Tuebingen, Germany

• Hannibal Baccouche, MD · Department of Cardiology, Robert Bosch Krankenhaus, Stuttgart, Germany

• Hardy Baumbach, MD · Department of Cardiovascular Surgery, Robert Bosch Krankenhaus Stuttgart, Germany

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-08-31

Primary Completion

2010-08-31

Completion

2010-08-31

Countries

• Germany

Study Locations