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

Sponsor
Udo Sechtem (Other)
Overall Status
Terminated
CT.gov ID
NCT00511160
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
36
Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Myocardial biopsies with TRU CUT 14 Gauge needle
  • Procedure: Endomyocardial biopsies
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
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
Study Start Date :
Aug 1, 2007
Actual Primary Completion Date :
Aug 1, 2010
Actual Study Completion Date :
Aug 1, 2010

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. 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 [2 years]

    Secondary Outcome Measures

    1. Correlation of non-invasive myocarditis screening exams (cardiac magnetic resonance, ecg, history, inflammatory markers) with biopsy results [2 years]

    2. Prognostic value of virus prevalence for the postoperative course [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Udo Sechtem, Prof. Udo Sechtem, Robert Bosch Gesellschaft für Medizinische Forschung mbH
    ClinicalTrials.gov Identifier:
    NCT00511160
    Other Study ID Numbers:
    • RBK103
    First Posted:
    Aug 3, 2007
    Last Update Posted:
    Oct 5, 2016
    Last Verified:
    Oct 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Udo Sechtem, Prof. Udo Sechtem, 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

    Study Results

    No Results Posted as of Oct 5, 2016