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

This study has suspended participant recruitment.
(Study suspended due to logistical/personnel difficulties)
Sponsor:
Information provided by:
Robert Bosch Gesellschaft für Medizinische Forschung mbH
ClinicalTrials.gov Identifier:
NCT00511160
First received: August 2, 2007
Last updated: September 17, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention
Myocarditis
Procedure: Myocardial biopsies with TRU CUT 14 Gauge needle
Procedure: Endomyocardial biopsies

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Official Title: Prevalence of Cardiotropic Viruses in Cardiac Surgery Patients Without Clinical Evidence of Myocarditis or Myocarditic Sequelae

Resource links provided by NLM:


Further study details as provided by Robert Bosch Gesellschaft für Medizinische Forschung mbH:

Primary Outcome Measures:
  • 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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation of non-invasive myocarditis screening exams (cardiac magnetic resonance, ecg, history, inflammatory markers) with biopsy results [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Prognostic value of virus prevalence for the postoperative course [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: August 2007
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: S
Study arm: Cardiac surgery group
Procedure: Myocardial biopsies with TRU CUT 14 Gauge needle
Myocardial needle biopsy and right atrial appendectomy
Other Name: TRU CUT 14 Gauge needle
Active Comparator: C
Routine cardiology group
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00511160

Locations
Germany
Robert Bosch Krankenhaus, Auerbachstrasse 110
Stuttgart, Baden-Wuerttemberg, Germany, 70376
Sponsors and Collaborators
Robert Bosch Gesellschaft für Medizinische Forschung mbH
Investigators
Study Chair: Udo P Sechtem, MD Head of Cardiology, Robert Bosch Krankenhaus, Stuttgart, Germany
Study Director: 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
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Robert Bosch Hospital, Division of Cardiology
ClinicalTrials.gov Identifier: NCT00511160     History of Changes
Other Study ID Numbers: RBK103
Study First Received: August 2, 2007
Last Updated: September 17, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by Robert Bosch Gesellschaft für Medizinische Forschung mbH:
myocarditis
parvovirus B19 (PVB19)
human herpes virus 6 (HHV6)
cardiac magnetic resonance tomography (CMR)

Additional relevant MeSH terms:
Myocarditis
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014