Skip to main content
OpenTrials
Completed

NCT Number: NCT03068858

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, 100037, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

real-time feedback of SYNTAX score category

Diagnostic Test

Primary outcomes

  1. Inappropriate rate of coronary revascularization

    Time frame: 1 month after study completion

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

Secondary outcomes

  1. The proportion of inappropriate PCI

    Time frame: 1 month after study completion

    Inappropriate rate of percutaneous coronary intervention (PCI) will be adjudicated by Chinese appropriate use criteria for coronary revascularization.

  2. The proportion of inappropriate CABG

    Time frame: 1 month after study completion

    Inappropriate rate of coronary artery bypass graft (CABG) will be adjudicated by Chinese appropriate use criteria for coronary revascularization.

  3. The proportion of utilizing PCI procedures

    Time frame: 1 month after study completion

    The proportion of patients who undergo percutaneous coronary intervention (PCI) among total patients

  4. The proportion of utilizing CABG procedures

    Time frame: 1 month after study completion

    The proportion of patients who undergo coronary artery bypass graft (CABG) among total patients

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Mar 3, 2017
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.