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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
History of Changes
  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:

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

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
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 May 21, 2013