The Effect of an Optimal Heart Team Implementation Protocol on the Stability of Decision-making for Complex Coronary Artery Disease-a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Overall percent agreement
研究概览
简要总结
This study is aimed to evaluate the effect of the optimal heart team implementation protocol on the stability of decision-making for patients with complex coronary artery disease.
详细描述
Current guidelines recommend a heart team in the decision making for patients with complex coronary artery disease (CAD). Previous study reported that the agreement between heart teams for revascularization decision-making in complex CAD patients was moderate. Potential factors associated with decision discrepancies were summarized in several aspects and a detailed heart team implementation protocol was generated and further validation is needed. This study is designed to evaluate the effect of the optimal heart team implementation protocol on the stability of decision-making for patients with complex coronary artery disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria for patients:
- •Inclusion Criteria:
- •Patients with stable CAD according to the National Cardiovascular Data Registry (NCDR) CathPCI criteria (stable angina, no or silent myocardial ischemia) and angiographically confirmed 3-vessel disease or left main disease.
排除标准
- •prior percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG);
- •cardiac troponin I (CTnI) greater than the local laboratory upper limit of normal or recent myocardial infarction with CTnI levels still elevated;
- •concomitant severe valvular disease, macrovascular disease, or huge ventricular aneurysm requiring surgery;
- •concomitant atrial fibrillation or severe arrhythmia
- •Eligibility Criteria for specialists:
- •Inclusion Criteria for interventional cardiologists:
- •Annual PCI volume ≥200
- •Annual left main PCI volume ≥25
- •Capable of chronic total occlusion(CTO) PCI
- •Clinical researcher experience in coronary revascularization
- •Proficient in clinical guidelines
- •Inclusion Criteria for cardiac surgeons:
- •CABG total volume ≥200
- •Proficient in both on-pump and off-pump CABG
- •Clinical researcher experience in coronary revascularization
- •Proficient in clinical guidelines
- •Inclusion Criteria for non-interventional cardiologists:
- •Proficient in clinical guidelines
研究组 & 干预措施
optimal heart team group
Heart teams in this group will be established according to the optimal heart team protocol. Each team consists of two interventional cardiologists and two cardiac surgeons. Team members will be trained systematically before the heart team meeting.
干预措施: optimal heart team protocol (Behavioral)
conventional heart team group
Heart teams in this group will be established according to the basic elements recommended by guidelines. Each team consists of an interventional cardiologist, a cardiac surgeon, and a non-interventional cardiologist. No team training will be held before the heart team meeting.
结局指标
主要结局
Overall percent agreement
时间窗: through study completion, an average of 1 year
The proportion of patients who received unanimous decision recommendations from the heart team
次要结局
- Inappropriate decision rate(through study completion, an average of 1 year)
- Compliance rate in real-world treatment(through study completion, an average of 1 year)
- Kappa value of heart team decision-making(through study completion, an average of 1 year)
- Reproducibility of decision-making(At 1-month after first phase of heart team meeting)