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

This study has been terminated.
(Study suspended due to logistical/personnel difficulties)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00511160
First Posted: August 3, 2007
Last Update Posted: October 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Udo Sechtem, Dr. Margarete Fischer-Bosch-Institut für Klinische Pharmakologie (IKP) am Robert-Bosch-Krankenhaus (RBK)
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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 Udo Sechtem, Dr. Margarete Fischer-Bosch-Institut für Klinische Pharmakologie (IKP) am Robert-Bosch-Krankenhaus (RBK):

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 ]

Secondary Outcome Measures:
  • Correlation of non-invasive myocarditis screening exams (cardiac magnetic resonance, ecg, history, inflammatory markers) with biopsy results [ Time Frame: 2 years ]
  • Prognostic value of virus prevalence for the postoperative course [ Time Frame: 2 years ]

Enrollment: 120
Study Start Date: August 2007
Study Completion Date: August 2010
Primary Completion Date: August 2010 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00511160


Locations
Germany
Robert Bosch Krankenhaus, Auerbachstrasse 110
Stuttgart, Baden-Wuerttemberg, Germany, 70376
Sponsors and Collaborators
Udo Sechtem
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

Responsible Party: Udo Sechtem, Prof. Udo Sechtem, Dr. Margarete Fischer-Bosch-Institut für Klinische Pharmakologie (IKP) am Robert-Bosch-Krankenhaus (RBK)
ClinicalTrials.gov Identifier: NCT00511160     History of Changes
Other Study ID Numbers: RBK103
First Submitted: August 2, 2007
First Posted: August 3, 2007
Last Update Posted: October 5, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Udo Sechtem, Dr. Margarete Fischer-Bosch-Institut für Klinische Pharmakologie (IKP) am Robert-Bosch-Krankenhaus (RBK):
myocarditis
parvovirus B19 (PVB19)
human herpes virus 6 (HHV6)
cardiac magnetic resonance tomography (CMR)

Additional relevant MeSH terms:
Myocarditis
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases