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NCT04217031 Clinical Trial

Decision Variability Between Different Heart Teams for Complex Coronary Artery Diseases

Coronary Artery Disease Clinical Trial

Official title:
Decision Variability Between Different Heart Teams for Complex Coronary Artery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04217031
Other study ID # 2019-1303
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 3, 2020
Est. completion date March 1, 2021

Study information
Verified date August 2021
Source China National Center for Cardiovascular Diseases
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 101
Est. completion date March 1, 2021
Est. primary completion date March 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• No intervention
No intervention

Locations
Country Name City State
China Fuwai hospital Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Kappa value of decisions Kappa value of decisions between different heart teams at the end of enrollment (6 months)
Secondary Concordance rate of decisions Concordance rate of decisions between different heart teams at the end of enrollment (6 months)
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