Prospective Clinical Observational Study of Humanin Isoforms in Cardiac Muscle and Blood Plasma and Their Association to Major Complications After Cardiac Operation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Mortality
研究概览
简要总结
Objective of the study is to clarify humanin-like peptide concentration in myocard tissue and in blood and to study if its concentration level is related to early complication occurrence and frequency after cardiac operation.
Hypothesis of the study is that previously described elements are related to each other.
详细描述
Data collection: Historical medical and preoperative data, operation data (type of operation performed and its details), detailed postoperative course (occurrence of complications).
Specimen collection:
- Tissue sample is taken during the operation from the right atrial appendage of the heart and the sample is frozen at -80 C.
- Blood samples are taken just before the operation, one hour after aortic cross-clamp removal and the next morning after the operation. Samples are processed and blood plasma is frozen at -80 C.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at least 18 years
- •Ischemic heart disease in medical history
- •Planned on-pump coronary artery bypass graft (CABG) operation
- •Signed informed consent by patient
排除标准
- •Age <18 years
- •Planned isolate valve or aortic operation
- •Patient is in another study with an intervention
- •Absence of signed informed consent
结局指标
主要结局
Mortality
时间窗: 30 days
30-day all-cause mortality
Major complications: myocardial infarction.
时间窗: 30 days
Diagnosed myocardial infarction.
Major complications: acute kidney injury.
时间窗: 30 days
Diagnosed acute kidney failure (KDIGO stage).
Major complications: stroke.
时间窗: 30 days
Diagnosed stroke.
次要结局
未报告次要终点
研究者
Henery Kroon
Researcher
University of Tartu