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

NCT00511160 | Terminated DMC

• 1 other identifier: RBK103
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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. 1.Correlation of non-invasive myocarditis screening exams (cardiac magnetic resonance, ecg, history, inflammatory markers) with biopsy results
2. 2.Prognostic value of virus prevalence for the postoperative course

Conditions

Myocarditis

Keywords

myocarditis; parvovirus B19 (PVB19); human herpes virus 6 (HHV6); cardiac magnetic resonance tomography (CMR)

Outcome Measures

Primary Outcomes (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 Outcomes (2)

• Correlation of non-invasive myocarditis screening exams (cardiac magnetic resonance, ecg, history, inflammatory markers) with biopsy results

  2 years

• Prognostic value of virus prevalence for the postoperative course

  2 years

Study Arms (2)

S

ACTIVE COMPARATOR

Study arm: Cardiac surgery group

Procedure: Myocardial biopsies with TRU CUT 14 Gauge needle

C

ACTIVE COMPARATOR

Routine cardiology group

Procedure: Endomyocardial biopsies

Interventions

Myocardial biopsies with TRU CUT 14 Gauge needle PROCEDURE

Myocardial needle biopsy and right atrial appendectomy

Also known as: TRU CUT 14 Gauge needle

S

Endomyocardial biopsies PROCEDURE

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

C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cardiac surgery with cardiopulmonary bypass

You may not qualify if:

• No ability to give informed consent
• presence of so far accepted parvovirus/herpesvirus associated comorbidities
• contraindications for magnetic resonance

Sponsors & Collaborators

• Udo Sechtem: lead

Study Sites (1)

Robert Bosch Krankenhaus, Auerbachstrasse 110

Stuttgart, Baden-Wurttemberg, 70376, Germany

Location

MeSH Terms

Conditions

Myocarditis

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Study Officials

• Udo P Sechtem, MD

  Head of Cardiology, Robert Bosch Krankenhaus, Stuttgart, Germany

  STUDY CHAIR

• 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

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Udo Sechtem

Study Record Dates

• First Submitted: August 2, 2007
• First Posted: August 3, 2007
• Study Start: August 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: October 5, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)