Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00511160
Status:
TERMINATED
Last Update Posted:
2016-10-05
First Post:
2007-08-02
Brief Title:
Cardiotropic Viruses in Cardiac Surgery Patients Without Clinical Evidence of Myocarditis or Myocarditic Sequelae
Sponsor:
Udo Sechtem
Organization:
Robert Bosch Gesellschaft für Medizinische Forschung mbH
Study Overview
Official Title:
Prevalence of Cardiotropic Viruses in Cardiac Surgery Patients Without Clinical Evidence of Myocarditis or Myocarditic Sequelae
Status:
TERMINATED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study suspended due to logisticalpersonnel difficulties
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor HHV6 via pcr techniquesand 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
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 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None