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

Udo Sechtem

Status: Terminated

Conditions: Myocarditis

Treatments: Procedure: Endomyocardial biopsies; Procedure: Myocardial biopsies with TRU CUT 14 Gauge needle

Study type: Interventional

Funder types: Other

Identifiers

NCT00511160

RBK103

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

S

Active Comparator group

Description:

Study arm: Cardiac surgery group

Treatment:

Procedure: Myocardial biopsies with TRU CUT 14 Gauge needle

C

Active Comparator group

Description:

Routine cardiology group

Treatment:

Procedure: Endomyocardial biopsies