NCT01409525Unknown不适用
Observational, Prospective, Exploratory Study to Evaluate the Rate of Microbial Colonization Over Native Calcified Cardiac Valves
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To asses the rate of bacterial colonization over degenerative cardiac valves and to discover whether there is a link to a specific micro-organism.
研究概览
简要总结
The purpose of this observational, exploratory study in patients undergoing any cardiac valve replacement or repair is to assess the rate of bacterial colonization over native degenerative calcified cardiac valves.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be obtained from the subject or his/her legal guardian before any assessment is performed
- •Male or Female subject, 50 years or older
- •Subjects are scheduled to go through any cardiac valve replacement or repair due to degenerative calcified process. For control, subjects with no evidence of valve disease
排除标准
- •Subjects have an established or indicated history of IE.
- •Subjects have complaint that might indicate IE- intermittent fever and physical finding according to IE diagnosis criteria (not including a heart murmur)
- •Subjects are current users or have a close history of drug abuse
结局指标
主要结局
To asses the rate of bacterial colonization over degenerative cardiac valves and to discover whether there is a link to a specific micro-organism.
时间窗: Patients will be followed for the duration of their hospitalization, average of 5 days.
次要结局
- Correlation between baseline demographic, clinical and laboratory parameters to degenerative cardiac valve disease(Patients will be followed for the duration of their hospitalization, average of 5 days.)
研究者
研究点 (1)
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