NCT04217031

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 3, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

January 3, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

1.2 years

First QC Date

December 31, 2019

Last Update Submit

August 14, 2021

Conditions

Coronary Artery Disease

Keywords

Heart teamDecision makingComplex coronary artery disease

Outcome Measures

Primary Outcomes (1)

  • Kappa value of decisions

    Kappa value of decisions between different heart teams

    at the end of enrollment (6 months)

Secondary Outcomes (1)

  • Concordance rate of decisions

    at the end of enrollment (6 months)

Study Arms (1)

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

No interventionOTHER

No intervention

Decision variability assessment group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai hospital

Beijing, Beijing Municipality, 100032, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2019

First Posted

January 3, 2020

Study Start

January 3, 2020

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

August 17, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)