Prevalence of Cardiotropic Viruses in Cardiac Surgery Patients Without Clinical Evidence of Myocarditis or Myocarditic Sequelae
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cardiac surgery with cardiopulmonary bypass
排除标准
- •No ability to give informed consent
- •presence of so far accepted parvovirus/herpesvirus associated comorbidities
- •contraindications for magnetic resonance
结局指标
主要结局
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
时间窗: 2 years
次要结局
- 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)
研究者
Udo Sechtem
Prof. Udo Sechtem
Robert Bosch Gesellschaft für Medizinische Forschung mbH