Decision Variability Between Different Heart Teams for Complex Coronary Artery Diseases

Sponsor

China National Center for Cardiovascular Diseases (Other)

Overall Status

Completed

CT.gov ID

NCT04217031

Collaborator

(none)

101

Enrollment

Location

13.9

Actual Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Other: No intervention

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 Design

Study Type:

Observational

Actual Enrollment :

101 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Decision Variability Between Different Heart Teams for Complex Coronary Artery

Actual Study Start Date :

Jan 3, 2020

Actual Primary Completion Date :

Mar 1, 2021

Actual Study Completion Date :

Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Decision variability assessment group 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.	Other: No intervention No intervention

Arm

Intervention/Treatment

Decision variability assessment group

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.

Other: No intervention

No intervention

Outcome Measures

Primary Outcome Measures

Kappa value of decisions [at the end of enrollment (6 months)]
Kappa value of decisions between different heart teams

Secondary Outcome Measures

Concordance rate of decisions [at the end of enrollment (6 months)]
Concordance rate of decisions between different heart teams

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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