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

Primary Purpose

Myocarditis

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Myocardial biopsies with TRU CUT 14 Gauge needle
Endomyocardial biopsies
Sponsored by
Udo Sechtem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Myocarditis focused on measuring myocarditis, parvovirus B19 (PVB19), human herpes virus 6 (HHV6), cardiac magnetic resonance tomography (CMR)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Robert Bosch Krankenhaus, Auerbachstrasse 110

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

S

C

Arm Description

Study arm: Cardiac surgery group

Routine cardiology group

Outcomes

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

Secondary Outcome Measures

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

Full Information

First Posted
August 2, 2007
Last Updated
October 4, 2016
Sponsor
Udo Sechtem
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1. Study Identification

Unique Protocol Identification Number
NCT00511160
Brief Title
Cardiotropic Viruses in Cardiac Surgery Patients Without Clinical Evidence of Myocarditis or Myocarditic Sequelae
Official Title
Prevalence of Cardiotropic Viruses in Cardiac Surgery Patients Without Clinical Evidence of Myocarditis or Myocarditic Sequelae
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
Study suspended due to logistical/personnel difficulties
Study Start Date
August 2007 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Udo Sechtem

4. Oversight

Data Monitoring Committee
Yes

5. 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: 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocarditis
Keywords
myocarditis, parvovirus B19 (PVB19), human herpes virus 6 (HHV6), cardiac magnetic resonance tomography (CMR)

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
S
Arm Type
Active Comparator
Arm Description
Study arm: Cardiac surgery group
Arm Title
C
Arm Type
Active Comparator
Arm Description
Routine cardiology group
Intervention Type
Procedure
Intervention Name(s)
Myocardial biopsies with TRU CUT 14 Gauge needle
Other Intervention Name(s)
TRU CUT 14 Gauge needle
Intervention Description
Myocardial needle biopsy and right atrial appendectomy
Intervention Type
Procedure
Intervention Name(s)
Endomyocardial biopsies
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Correlation of non-invasive myocarditis screening exams (cardiac magnetic resonance, ecg, history, inflammatory markers) with biopsy results
Time Frame
2 years
Title
Prognostic value of virus prevalence for the postoperative course
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Udo P Sechtem, MD
Organizational Affiliation
Head of Cardiology, Robert Bosch Krankenhaus, Stuttgart, Germany
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ulrich FW Franke, MD
Organizational Affiliation
Head of Cardiovascular Surgery, Robert Bosch Krankenhaus, Stuttgart, Germany
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Reinhardt Kandolf, MD
Organizational Affiliation
Director of Institute of Molecular Pathology University Tuebingen, Germany
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hannibal Baccouche, MD
Organizational Affiliation
Department of Cardiology, Robert Bosch Krankenhaus, Stuttgart, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hardy Baumbach, MD
Organizational Affiliation
Department of Cardiovascular Surgery, Robert Bosch Krankenhaus Stuttgart, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert Bosch Krankenhaus, Auerbachstrasse 110
City
Stuttgart
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
70376
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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