CClinicalTrials.gg
CompletedNCT04217031Updated Aug 17, 2021

Decision Variability Between Different Heart Teams for Complex Coronary Artery Diseases

An observational study in Coronary Artery Disease, sponsored by China National Center for Cardiovascular Diseases. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-17.

Sponsored by China National Center for Cardiovascular Diseases · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
101
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • Heart team
  • Decision making
  • Complex coronary artery disease
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 101 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

China National Center for Cardiovascular Diseases is the lead sponsor of 256 studies on the registry; 134 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Eligible patients will be randomly selected and enrolled from a coronary angiography registry database at Fuwai hospital to make sure the representativity of enrolled patients.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
101 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • OtherNo intervention

    No intervention

06

What researchers measure

Primary outcomes

  1. Kappa value of decisions

    Kappa value of decisions between different heart teams

    Time frame: at the end of enrollment (6 months)

Secondary outcomes

  1. Concordance rate of decisions

    Concordance rate of decisions between different heart teams

    Time frame: at the end of enrollment (6 months)

07

Study locations

1 site
  • Fuwai hospital
    Beijing, Beijing 100032, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04217031
Lead sponsor
China National Center for Cardiovascular Diseases
Responsible party
Sponsor
First posted
Jan 3, 2020
Start date
Jan 3, 2020
Primary completion
Mar 1, 2021
Completion
Mar 1, 2021
Last update
Aug 17, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion