跳至主要内容
临床试验/NCT03068858
NCT03068858已完成不适用

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

China National Center for Cardiovascular Diseases1 个研究点 分布在 1 个国家目标入组 3,245 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

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

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

No Intervention

Cardiologists' subjective SYNTAX score category judgement will be recorded during the angiography.

SYNTAX score category feedback group

Experimental

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)

研究者

发起方
China National Center for Cardiovascular Diseases
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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