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

October 4, 2016 updated by: Udo Sechtem

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Wuerttemberg
      • Stuttgart, Baden-Wuerttemberg, Germany, 70376
        • Robert Bosch Krankenhaus, Auerbachstrasse 110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ACTUAL)

August 1, 2010

Study Registration Dates

First Submitted

August 2, 2007

First Submitted That Met QC Criteria

August 2, 2007

First Posted (ESTIMATE)

August 3, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

October 5, 2016

Last Update Submitted That Met QC Criteria

October 4, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBK103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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