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

NCT03068858 | Completed DMC

• 1 other identifier: 20160826
• Study Type: interventional
• Target: 3,245
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Inappropriate rate of coronary revascularization

  Inappropriate rate will be adjudicated by Chinese appropriate use criteria for coronary revascularization.

  1 month after study completion

Secondary Outcomes (4)

• The proportion of inappropriate PCI

  1 month after study completion

• The proportion of inappropriate CABG

  1 month after study completion

• The proportion of utilizing PCI procedures

  1 month after study completion

• The proportion of utilizing CABG procedures

  1 month after study completion

Study Arms (2)

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.

Diagnostic Test: real-time feedback of SYNTAX score category

Controlled group

NO INTERVENTION

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

Interventions

real-time feedback of SYNTAX score category DIAGNOSTIC_TEST

SYNTAX score category feedback group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Have prior CABG;
• Have stage PCI;
• Have no assigned scenario in Chinese appropriate use criteria.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

China National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (1)

• 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.

  PMID: 32452896 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2017
• First Posted: March 3, 2017
• Study Start: September 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: March 1, 2018
• Last Updated: June 6, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)