Clinical Trial: Cardiotropic Viruses in Cardiac Surgery Patients Without Clinical Evidence of Myocarditis or Myocarditic Sequelae
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Prevalence of Cardiotropic Viruses in Cardiac Surgery Patients Without Clinical Evidence of Myocarditis or Myocarditic Sequelae
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:
- Correlation of non-invasive myocarditis screening exams (cardiac magnetic resonance, ecg, history, inflammatory markers) with biopsy results
- 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 Summary:
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.
Sponsor: Udo Sechtem
Current Primary Outcome: 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 [ Time Frame: 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Correlation of non-invasive myocarditis screening exams (cardiac magnetic resonance, ecg, history, inflammatory markers) with biopsy results [ Time Frame: 2 years ]
- Prognostic value of virus prevalence for the postoperative course [ Time Frame: 2 years ]
Original Secondary Outcome: Same as current
Information By: Robert Bosch Gesellschaft für Medizinische Forschung mbH
Dates:
Date Received: August 2, 2007
Date Started: August 2007
Date Completion:
Last Updated: October 4, 2016
Last Verified: October 2016
