E-CABG: European Multicenter Study on the Outcome After Coronary Artery Bypass Grafting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
The E-CABG registry is a multicenter, European registry collecting data on the preoperative characteristics, treatment strategies and outcome of patients undergoing isolated coronary artery bypass grafting (CABG).
详细描述
Improvements in the surgical treatment of coronary artery disease are possible only when implementation of current methods and development of new methods are based on the solid ground of large and reliable clinical data. Furthermore, clinical findings assume even more significance when detected in study populations from different institutions with heterogeneous referral pathways, baseline clinical characteristics and perioperative treatment strategies. The rationale of this European multicenter study is therefore to prospectively collect data on baseline characteristics, operative and anesthesiological methods and postoperative outcome of patients undergoing CABG in eleven cardiac surgery centers from five European countries. This multicenter prospective registrywill provide data to evaluate the prognostic impact of a number of patients' risk factors as well as the efficacy and safety of operative methods and drugs used during the pre-, peri- and postoperative period.
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
- •Patients of aged > 18 years undergoing isolated CABG for stable coronary artery disease or acute coronary syndrome. Patients undergoing Maze procedure will be included in this registry.
排除标准
- •Patients undergoing any other major cardiac surgery procedure will be excluded from this registry.
结局指标
主要结局
Mortality
时间窗: The outcome measure will be assessed at time points up to 10 years after surgery
Any death occurring after surgery
次要结局
- Stroke(The outcome measure will be assessed at time points up to 10 years after surgery)
- Prolonged use of inotropes(Participants will be followed for the duration of hospital stay (expected: 10 days))
- Intra-aortic balloon pump(Participants will be followed for the duration of hospital stay (expected: 10 days))
- ECMO(Participants will be followed for the duration of hospital stay (expected: 10 days))
- Repeat revascularization(The outcome measure will be assessed at time points up to 10 years after surgery)
- Wound infection(Participants will be followed up for 3 months after surgery)
- Blood losses(Participants will be followed 12 hours after surgery)
- Nadir hematocrit(Participants will be followed during the operation day)
- Use of blood products(Participants will be followed for the duration of hospital stay (expected: 10 days))
- Use of prothrombotic drugs(Participants will be followed for the duration of hospital stay (expected: 10 days))
- Resternotomy for bleeding(Participants will be followed for the duration of hospital stay (expected: 10 days))
- Atrial fibrillation(Participants will be followed for the duration of hospital stay (expected: 10 days))
- Renal replacement therapy(Participants will be followed for the duration of hospital stay (expected: 10 days))
- Highest level of serum creatinine(Participants will be followed for the duration of hospital stay (expected: 10 days))
- Length of stay in the intensive care unit(Participants will be followed for the duration of hospital stay (expected: 10 days))
- Pericardial effusion(Participants will be followed up to 3 months after surgery.)
- Postoperative use of antibiotics(Participants will be followed for the duration of hospital stay (expected: 10 days))
- Gastrointestinal complications(Participants will be followed for the duration of hospital stay (expected: 10 days))
- Myocardial infarction(The outcome measure will be assessed at time point up to 10 years after surgery)
研究者
Fausto Biancari
Professor
University of Oulu