Real-time Feedback of SYNTAX Score Category During Coronary Angiographies to Improve Appropriateness of Coronary Revascularization for Patients With Stable Coronary Artery Diseases: a Before-and-after Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,245
- 试验地点
- 1
- 主要终点
- Inappropriate rate of coronary revascularization
研究概览
简要总结
The SYNTAX score (SS) has been recommended by clinical guideline and appropriate use criteria for coronary revascularization (CR) to provide guidance on optimal treatment strategies for patients with stable coronary artery diseases (CAD). However, discrepancy in SS between angiographic core lab (ACL) and cardiologists has been found. Whether the misestimate will lead to inappropriate CR and whether a SS intervention will improve CR appropriateness in patients with stable CAD remain unknown.
Thus, our study aims at evaluating whether a real-time feedback from ACL rightafter the angiographies will improve CR appropriateness. A before-and-after controlled trial was designed. In the first period of time, stable CAD patients undergoing elective coronary angiographies with at least one coronary lesion stenosis ≥ 50% from one Chinese cardiac center will be continuously recruited as the control group. In the second period, eligible patients will be recruited continuously and a real-time SS category feedback from ACL rightafter the angiography will be given to the cardiologists. Appropriateness of treatment strategies in two groups will be analyzed to determine whether a real-time SS feedback can improve the treatment appropriateness. The appropriateness of treatment strategies will be adjudicated by Chinese version appropriate use criteria for CR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Undergo elective coronary angiography with at least one coronary lesion stenosis ≥ 50%;
- •Patients with stable coronary artery diseases (stable angina, no or non-ischemic symptom);
- •Written informed consent.
排除标准
- •Have prior CABG;
- •Have stage PCI;
- •Have no assigned scenario in Chinese appropriate use criteria.
研究组 & 干预措施
Controlled group
Cardiologists' subjective SYNTAX score category judgement will be recorded during the angiography.
SYNTAX score category feedback group
A real-time SYNTAX score category feedback from angiographic core lab will be given to the cardiologists rightafter the angiographies.
干预措施: real-time feedback of SYNTAX score category (Diagnostic Test)
结局指标
主要结局
Inappropriate rate of coronary revascularization
时间窗: 1 month after study completion
Inappropriate rate will be adjudicated by Chinese appropriate use criteria for coronary revascularization.
次要结局
- The proportion of inappropriate CABG(1 month after study completion)
- The proportion of utilizing CABG procedures(1 month after study completion)
- The proportion of utilizing PCI procedures(1 month after study completion)
- The proportion of inappropriate PCI(1 month after study completion)
