NCT00511160

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Udo Sechtem · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myocarditis

Interventions

Type	Name	Description
PROCEDURE	Myocardial biopsies with TRU CUT 14 Gauge needle	Myocardial needle biopsy and right atrial appendectomy
PROCEDURE	Endomyocardial 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

Timeline

• Start date: 2007-08-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2007-08-03
• Last updated: 2016-10-05

Locations

1 site across 1 country: Germany