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

Not Applicable

Terminated

• Conditions: Myocarditis
• Interventions: Procedure: Endomyocardial biopsies; Procedure: Myocardial biopsies with TRU CUT 14 Gauge needle

• Registration Number: NCT00511160
• Lead Sponsor: Udo Sechtem

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.

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 Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-02
• Study First Submitted QC: 2007-08-02
• Study First Posted: 2007-08-03
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-04
• Last Update Posted: 2016-10-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C	Endomyocardial biopsies	Routine cardiology group
S	Myocardial biopsies with TRU CUT 14 Gauge needle	Study arm: Cardiac surgery group

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Robert Bosch Krankenhaus, Auerbachstrasse 110; 🇩🇪 Stuttgart, Baden-Wuerttemberg, Germany