Vascular Events In Surgery patIents cOhort evaluatioN - Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15,989
- 试验地点
- 24
- 主要终点
- Myocardial injuries that were not identified clinically during the first 5 days after surgery
研究概览
简要总结
Worldwide over 2 million adults (>30,000 Canadians) undergo heart surgery annually. Although heart surgery provides important survival benefits, it is associated with potential major complications such as death, stroke, and heart attack. There is promising evidence that measurement of heart injury markers after surgery will identify patients at risk of death or major complications.
This study will determine the current incidence of major complications in a representative sample of 15,000 contemporary adult patients undergoing heart surgery. Knowing the current burden of complications will inform clinicians, administrators, government and granting agencies about resources required to address the problem. This study will also establish the role of measuring heart injury markers to identify important heart injury after heart surgery and the proportion that would go undetected without routine heart injury marker monitoring. This information will facilitate further studies of timely interventions. In summary, the VISION Cardiac Surgery Study addresses fundamental questions that will have profound public health implications given the millions of adults worldwide who undergo heart surgery annually.
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 ≥ 18 years.
- •Patients who have undergone cardiac surgery. This includes coronary artery bypass grafting and all open heart procedures such as valvular repairs/replacement.
排除标准
- •Previously enrolled in the VISION Cardiac Surgery Study.
- •Patients who have undergone an isolated pericardial window, pericardiectomy, permanent pacemaker or defibrillator implantation.
结局指标
主要结局
Myocardial injuries that were not identified clinically during the first 5 days after surgery
时间窗: 5 days after surgery
Myocardial injuries that were not identified clinically during the first 5 days after surgery
All-cause mortality at 30-days after surgery
时间窗: 30 days after surgery
All-cause mortality at 30-days after surgery
Composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device
时间窗: 1 year after surgery
Major vascular complications at 1-year after surgery (i.e., a composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, nonfatal stroke, and mechanical assist device)
次要结局
- New dialysis(1 year after surgery)
- Chronic incisional pain(1 year after surgery)
- Composite of vascular death, nonfatal myocardial infarction, nonfatal stroke, and mechanical assist device(30 days after surgery)
- Total mortality(1 year after surgery)
- Cardiac transplant(1 year after surgery)
- Congestive heart failure(1 year after surgery)
- Frailty(1 year after surgery)
- Non-fatal cardiac arrest(1 year after surgery)
- Vascular mortality(1 year after surgery)
- Myocardial infarction(1 year after surgery)
- Deep venous thrombosis(1 year after surgery)
- Infection(1 year after surgery)
- Re-hospitalization for a vascular reason(1 year after surgery)
- Stroke(1 year after surgery)
- Implantation of mechanical assist device(1 year after surgery)
- Repeat cardiac revascularization procedures(1 year after surgery)
- New atrial fibrillation(1 year after surgery)
- Pulmonary embolus(1 year after surgery)
- Major bleeding(1 year after surgery)
研究者
Andre Lamy
Professor and Cardiac Surgeon
Population Health Research Institute