Cardiotropic Viruses in Cardiac Surgery Patients Without Clinical Evidence of Myocarditis or Myocarditic Sequelae - Full Text View

Sponsor:	Dr. Margarete Fischer-Bosch-Institut für Klinische Pharmakologie (IKP) am Robert-Bosch-Krankenhaus (RBK)
Information provided by:	Dr. Margarete Fischer-Bosch-Institut für Klinische Pharmakologie (IKP) am Robert-Bosch-Krankenhaus (RBK)
ClinicalTrials.gov Identifier:	NCT00511160

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:

Correlation of non-invasive myocarditis screening exams (cardiac magnetic resonance, ecg, history, inflammatory markers) with biopsy results
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:	Basic Science, Single Blind (Investigator), Active Control, Parallel Assignment
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 Surgery

U.S. FDA Resources

Further study details as provided by 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 ] [ 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
S: Active Comparator Study arm: Cardiac surgery group	Procedure: Myocardial biopsies with TRU CUT 14 Gauge needle Myocardial needle biopsy and right atrial appendectomy
C: Active Comparator 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, Baden-Wuerttemberg
Robert Bosch Krankenhaus, Auerbachstrasse 110
Stuttgart, Baden-Wuerttemberg, Germany, 70376

Sponsors and Collaborators

Dr. Margarete Fischer-Bosch-Institut für Klinische Pharmakologie (IKP) am Robert-Bosch-Krankenhaus (RBK)

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

Keywords provided by 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:

Heart Diseases
Cardiovascular Diseases
Myocarditis
Cardiomyopathies

ClinicalTrials.gov processed this record on February 08, 2010