Feasibility and Effectiveness of a Real-time Heart Team Approach in Complex Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 490
- 试验地点
- 1
- 主要终点
- 1-year major adverse cardiovascular and cerebrovascular events
研究概览
简要总结
This study is aimed to evaluate the clinical outcomes, efficiency and feasibility of the real-time heart team approach and the conventional heart team approach.
详细描述
This study is a multicenter, randomized controlled trial. According to the inclusion and exclusion criteria, patients with complex coronary artery disease undergoing elective coronary angiography will be prospectively enrolled in the study. Patients will be randomly assigned to the real-time heart team group and the conventional heart team group by block randomization. The real-time heart team group needs to conduct multidisciplinary heart team discussion during the coronary angiography process, while the traditional heart team group needs to conduct multidisciplinary heart team discussion offline and face-to-face after the coronary angiography process. This study will prospectively collect the patient information, heart team meeting process, clinical treatment, and clinical outcomes to evaluate the efficiency and feasibility and differences in clinical outcomes of patients under different heart team approaches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Significant stenosis in the left main or left main equivalent with or without stenosis in one of the other vessels[Significant stenosis is defined as: 1) a diameter stenosis of at least 50% reduction in luminal diameter by visual assessment or 2) any total occlusion (no age limitation and no exclusion of unfavorable anatomic features); Left main equivalent disease is defined as significant stenosis of the ostium of the left anterior descending and the ostium of the left circumflex.]
- •At least 1 significant stenosis (≥ 70% obstruction) in all 3 major epicardial territories supplying viable myocardium;
- •Other conditions that the interventional cardiologist considers necessary to discuss with cardiac surgeons due to technical and risk considerations.
排除标准
- •Less than 18 years of age;
- •Previous history of PCI or CABG;
- •Admitted for AMI, ECG and biomarker detection indicated acute stage;
- •Patients with severe heart valvular disease, major vascular disease, and giant ventricular aneurysm require surgical treatment;
- •Combined with AF or severe arrhythmia;
- •Other patients admitted to hospital due to emergency circumstances who are not suitable to wait for elective revascularization;
- •Rejection or exclusion of a revascularization mode (PCI or CABG);
- •Refuse to participate in the study.
结局指标
主要结局
1-year major adverse cardiovascular and cerebrovascular events
时间窗: At 1 year after the coronary angiography
a composite of all-cause mortality, myocardial infarction, stroke, unplanned revascularization, readmission due to reangina.
1-year major adverse cardiovascular and cerebrovascular events
时间窗: At 1 year after the coronary angiography
a composite of all-cause mortality, myocardial infarction, stroke, unplanned revascularization, readmission due to reangina.
次要结局
- success rate of heart team organization(through study completion, an average of 1 year)
- length of stay(through study completion, an average of 1 year)
- total cost(through study completion, an average of 3 year)
- individual clinical adverse events(At 1 year after the coronary angiography)
- revascularization decision-making guideline adherence(through study completion, an average of 1 year)
- individual clinical adverse events(At 1 year after the coronary angiography)
- workload of heart team specialists(through study completion, an average of 1 year)
- revascularization decision-making(through study completion, an average of 1 year)
- total cost(through study completion, an average of 3 year)
- time interval between the completion of coronary angiography and the final treatment(through treatment completion, an average of 60 days)
- heart team decision-making(through study completion, an average of 1 year)
- success rate of heart team organization(through study completion, an average of 1 year)
- length of stay(through study completion, an average of 1 year)