Decision Variability Between Different Heart Teams for Complex Coronary Artery Diseases

Completed

• Conditions: Coronary Artery Disease
• Interventions: Other: No intervention

• Registration Number: NCT04217031
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief Summary

The purposes of this study are 1) to explore the variability of decisions between different heart teams in complex coronary artery disease; 2) to evaluate the reasons of the discrepancy in decision making.

Detailed Description

Heart team has been recommended by guideline for optimizing the decision making for patients with complex coronary artery diseases (CAD). However, prior studies have demonstrated that heart team decision might have poor reproducibility, and the variability of heart team decision remains unknown.

Thus, the investigators designed a single-center, retrospective, cross-sectional study to explore the decision variability of heart team in CAD patients. The investigators will retrospectively recruit patients with angiographically confirmed 3-vessel or left main disease from a coronary angiography database at Fuwai hospital. Patients' baseline information will be collected. And different heart teams will be established and made decisions for the enrolled patients. First, the investigators will assess the decision variability between different heart teams. Secondary, the investigators will evaluate the reason of discrepancy by qualitative and quantitative analysis.

Study Timeline

• Study First Submitted: 2019-12-31
• Study First Submitted QC: 2019-12-31
• Study Start: 2020-01-03
• Study First Posted: 2020-01-03
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-14
• Last Update Posted: 2021-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• Patients with angiographically confirmed 3-vessel disease or left main disease

Exclusion Criteria

• Prior percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
• Myocardial infarction with acute phase judged by Electrocardiograph or biomarkers
• Combined with severe valvular disease, great vessel disease or huge ventricular aneurysm which need surgery
• Combined with atrial fibrillation or severe arrhythmia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Decision variability assessment group	No intervention	Patients with angiographically confirmed 3-vessel or left main disease will be enrolled. Patients data and heart team decision will be collected to analyze the variability between different heart team decisions.

Primary Outcome Measures

Name	Time	Method
Kappa value of decisions	at the end of enrollment (6 months)	Kappa value of decisions between different heart teams

Secondary Outcome Measures

Name	Time	Method
Concordance rate of decisions	at the end of enrollment (6 months)	Concordance rate of decisions between different heart teams

Trial Locations

Locations (1)

Fuwai hospital; 🇨🇳 Beijing, Beijing, China