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Effect of an Optimal Heart Team Protocol on Decision-making Stability

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
optimal heart team protocol
Sponsored by
China National Center for Cardiovascular Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Heart Team protocol, Coronary Artery Disease, decision-making agreement

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Eligibility Criteria for patients:

Inclusion Criteria:

Patients with stable CAD according to the National Cardiovascular Data Registry (NCDR) CathPCI criteria (stable angina, no or silent myocardial ischemia) and angiographically confirmed 3-vessel disease or left main disease.

Exclusion Criteria:

  1. prior percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG);
  2. cardiac troponin I (CTnI) greater than the local laboratory upper limit of normal or recent myocardial infarction with CTnI levels still elevated;
  3. concomitant severe valvular disease, macrovascular disease, or huge ventricular aneurysm requiring surgery;
  4. concomitant atrial fibrillation or severe arrhythmia

Eligibility Criteria for specialists:

Inclusion Criteria for interventional cardiologists:

  1. Annual PCI volume ≥200
  2. Annual left main PCI volume ≥25
  3. Capable of chronic total occlusion(CTO) PCI
  4. Clinical researcher experience in coronary revascularization
  5. Proficient in clinical guidelines

Inclusion Criteria for cardiac surgeons:

  1. CABG total volume ≥200
  2. Proficient in both on-pump and off-pump CABG
  3. Clinical researcher experience in coronary revascularization
  4. Proficient in clinical guidelines

Inclusion Criteria for non-interventional cardiologists:

1) Proficient in clinical guidelines

Sites / Locations

  • National Clinical Research Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

optimal heart team group

conventional heart team group

Arm Description

Heart teams in this group will be established according to the optimal heart team protocol. Each team consists of two interventional cardiologists and two cardiac surgeons. Team members will be trained systematically before the heart team meeting.

Heart teams in this group will be established according to the basic elements recommended by guidelines. Each team consists of an interventional cardiologist, a cardiac surgeon, and a non-interventional cardiologist. No team training will be held before the heart team meeting.

Outcomes

Primary Outcome Measures

Overall percent agreement
The proportion of patients who received unanimous decision recommendations from the heart team

Secondary Outcome Measures

Kappa value of heart team decision-making
Fliess's (more than 2 raters) and Cohen's (2 raters) kappa coefficients to evaluate inter-team, inter-specialist, and inter-round agreement for treatment decisions.
Inappropriate decision rate
According to the American College of Cardiology/American Association for Thoracic Surgery/American Heart Association 2017 Appropriate Use Criteria for coronary revascularization, the inappropriate decision rate od decision-making
Compliance rate in real-world treatment
Compliance is defined as the patient's actual treatment meeting the recommendations of either heart team
Reproducibility of decision-making
All cases will be discussed by the same heart team to evaluate the intra-team consistency in decision-making.

Full Information

First Posted
August 26, 2021
Last Updated
March 29, 2023
Sponsor
China National Center for Cardiovascular Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT05039567
Brief Title
Effect of an Optimal Heart Team Protocol on Decision-making Stability
Official Title
The Effect of an Optimal Heart Team Implementation Protocol on the Stability of Decision-making for Complex Coronary Artery Disease-a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 4, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China National Center for Cardiovascular Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is aimed to evaluate the effect of the optimal heart team implementation protocol on the stability of decision-making for patients with complex coronary artery disease.
Detailed Description
Current guidelines recommend a heart team in the decision making for patients with complex coronary artery disease (CAD). Previous study reported that the agreement between heart teams for revascularization decision-making in complex CAD patients was moderate. Potential factors associated with decision discrepancies were summarized in several aspects and a detailed heart team implementation protocol was generated and further validation is needed. This study is designed to evaluate the effect of the optimal heart team implementation protocol on the stability of decision-making for patients with complex coronary artery disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Heart Team protocol, Coronary Artery Disease, decision-making agreement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
optimal heart team group
Arm Type
Experimental
Arm Description
Heart teams in this group will be established according to the optimal heart team protocol. Each team consists of two interventional cardiologists and two cardiac surgeons. Team members will be trained systematically before the heart team meeting.
Arm Title
conventional heart team group
Arm Type
No Intervention
Arm Description
Heart teams in this group will be established according to the basic elements recommended by guidelines. Each team consists of an interventional cardiologist, a cardiac surgeon, and a non-interventional cardiologist. No team training will be held before the heart team meeting.
Intervention Type
Behavioral
Intervention Name(s)
optimal heart team protocol
Intervention Description
Heart teams in the experimental group will be established and trained based on the optimal heart team implementation protocol. The protocol included instructions on specialist selection, specialist training, team composition, team training and formal implementation precess.
Primary Outcome Measure Information:
Title
Overall percent agreement
Description
The proportion of patients who received unanimous decision recommendations from the heart team
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Kappa value of heart team decision-making
Description
Fliess's (more than 2 raters) and Cohen's (2 raters) kappa coefficients to evaluate inter-team, inter-specialist, and inter-round agreement for treatment decisions.
Time Frame
through study completion, an average of 1 year
Title
Inappropriate decision rate
Description
According to the American College of Cardiology/American Association for Thoracic Surgery/American Heart Association 2017 Appropriate Use Criteria for coronary revascularization, the inappropriate decision rate od decision-making
Time Frame
through study completion, an average of 1 year
Title
Compliance rate in real-world treatment
Description
Compliance is defined as the patient's actual treatment meeting the recommendations of either heart team
Time Frame
through study completion, an average of 1 year
Title
Reproducibility of decision-making
Description
All cases will be discussed by the same heart team to evaluate the intra-team consistency in decision-making.
Time Frame
At 1-month after first phase of heart team meeting

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Eligibility Criteria for patients: Inclusion Criteria: Patients with stable CAD according to the National Cardiovascular Data Registry (NCDR) CathPCI criteria (stable angina, no or silent myocardial ischemia) and angiographically confirmed 3-vessel disease or left main disease. Exclusion Criteria: prior percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG); cardiac troponin I (CTnI) greater than the local laboratory upper limit of normal or recent myocardial infarction with CTnI levels still elevated; concomitant severe valvular disease, macrovascular disease, or huge ventricular aneurysm requiring surgery; concomitant atrial fibrillation or severe arrhythmia Eligibility Criteria for specialists: Inclusion Criteria for interventional cardiologists: Annual PCI volume ≥200 Annual left main PCI volume ≥25 Capable of chronic total occlusion(CTO) PCI Clinical researcher experience in coronary revascularization Proficient in clinical guidelines Inclusion Criteria for cardiac surgeons: CABG total volume ≥200 Proficient in both on-pump and off-pump CABG Clinical researcher experience in coronary revascularization Proficient in clinical guidelines Inclusion Criteria for non-interventional cardiologists: 1) Proficient in clinical guidelines
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhe Zheng, MD,PhD
Organizational Affiliation
Fuwai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Clinical Research Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of an Optimal Heart Team Protocol on Decision-making Stability

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