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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00511160

Enrollment

120

Registered

2007-08-03

Start date

2007-08-31

Completion date

2010-08-31

Last updated

2016-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocarditis

Keywords

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

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.

Interventions

PROCEDUREMyocardial biopsies with TRU CUT 14 Gauge needle

Myocardial needle biopsy and right atrial appendectomy

PROCEDUREEndomyocardial 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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	2 years

Secondary

Measure	Time frame
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026