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

Coronary Revascularization Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03068858
• Other study ID #: 20160826
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: March 2018

Study information

• Verified date: June 2018
• Source: China National Center for Cardiovascular Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3245
• Est. completion date: March 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Appropriateness
• Coronary Revascularization
• Syntax Score

Intervention

Diagnostic Test:
• real-time feedback of SYNTAX score category

Locations

Country	Name	City	State
China	China National Center for Cardiovascular Diseases	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

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