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

Not Applicable

Completed

• Conditions: Syntax Score; Appropriateness; Coronary Revascularization
• Interventions: Diagnostic Test: real-time feedback of SYNTAX score category

• Registration Number: NCT03068858
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2017-02-19
• Study First Submitted QC: 2017-02-27
• Study First Posted: 2017-03-03
• Primary Completion: 2017-09
• Study Completion: 2018-03
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-03
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3245

Inclusion Criteria

1. Undergo elective coronary angiography with at least one coronary lesion stenosis ≥ 50%;
2. Patients with stable coronary artery diseases (stable angina, no or non-ischemic symptom);
3. Written informed consent.

Exclusion Criteria

1. Have prior CABG;
2. Have stage PCI;
3. Have no assigned scenario in Chinese appropriate use criteria.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
SYNTAX score category feedback group	real-time feedback of SYNTAX score category	A real-time SYNTAX score category feedback from angiographic core lab will be given to the cardiologists rightafter the angiographies.

Primary Outcome Measures

Name	Time	Method
Inappropriate rate of coronary revascularization	1 month after study completion	Inappropriate rate will be adjudicated by Chinese appropriate use criteria for coronary revascularization.

Secondary Outcome Measures

Name	Time	Method
The proportion of inappropriate CABG	1 month after study completion	Inappropriate rate of coronary artery bypass graft (CABG) will be adjudicated by Chinese appropriate use criteria for coronary revascularization.
The proportion of utilizing CABG procedures	1 month after study completion	The proportion of patients who undergo coronary artery bypass graft (CABG) among total patients
The proportion of utilizing PCI procedures	1 month after study completion	The proportion of patients who undergo percutaneous coronary intervention (PCI) among total patients
The proportion of inappropriate PCI	1 month after study completion	Inappropriate rate of percutaneous coronary intervention (PCI) will be adjudicated by Chinese appropriate use criteria for coronary revascularization.

Trial Locations

Locations (1)

China National Center for Cardiovascular Diseases; 🇨🇳 Beijing, Beijing, China