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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03068858
Enrollment
3245
Registered
2017-03-03
Start date
2016-09-30
Completion date
2018-03-31
Last updated
2018-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appropriateness, Coronary Revascularization, Syntax Score

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.

Interventions

DIAGNOSTIC_TESTreal-time feedback of SYNTAX score category

Sponsors

China National Center for Cardiovascular Diseases
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Inappropriate rate of coronary revascularization1 month after study completionInappropriate rate will be adjudicated by Chinese appropriate use criteria for coronary revascularization.

Secondary

MeasureTime frameDescription
The proportion of inappropriate PCI1 month after study completionInappropriate rate of percutaneous coronary intervention (PCI) will be adjudicated by Chinese appropriate use criteria for coronary revascularization.
The proportion of inappropriate CABG1 month after study completionInappropriate rate of coronary artery bypass graft (CABG) will be adjudicated by Chinese appropriate use criteria for coronary revascularization.
The proportion of utilizing PCI procedures1 month after study completionThe proportion of patients who undergo percutaneous coronary intervention (PCI) among total patients
The proportion of utilizing CABG procedures1 month after study completionThe proportion of patients who undergo coronary artery bypass graft (CABG) among total patients

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026