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

NCT ID: NCT03068858

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3245 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-03-31

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.

Conditions

Syntax Score; Appropriateness; Coronary Revascularization

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

real-time feedback of SYNTAX score category

Intervention Type: DIAGNOSTIC_TEST

Controlled group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

real-time feedback of SYNTAX score category

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

China National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, China

Countries

China

References

Lin S, Zhang H, Chen SP, Rao CF, Wu F, Zhou FJ, Wang Y, Yan HB, Dou KF, Wu YJ, Tang YD, Xie LH, Guan CD, Xu B, Zheng Z. Mis-estimation of coronary lesions and rectification by SYNTAX score feedback for coronary revascularization appropriateness. Chin Med J (Engl). 2020 Jun 5;133(11):1276-1284. doi: 10.1097/CM9.0000000000000827.

Reference Type: DERIVED

PMID: 32452896 (View on PubMed)

Other Identifiers

20160826

Identifier Type: -

Identifier Source: org_study_id