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

Study Overview
=================
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.

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

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Behavioral: optimal heart team protocol


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: optimal heart team group<br>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. | Behavioral: optimal heart team protocol<br>* 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.<br>|
| No Intervention: conventional heart team group<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall percent agreement | The proportion of patients who received unanimous decision recommendations from the heart team | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | through study completion, an average of 1 year | 
| 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 | through study completion, an average of 1 year | 
| Compliance rate in real-world treatment | Compliance is defined as the patient's actual treatment meeting the recommendations of either heart team | through study completion, an average of 1 year | 
| Reproducibility of decision-making | All cases will be discussed by the same heart team to evaluate the intra-team consistency in decision-making. | At 1-month after first phase of heart team meeting | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Team protocol, Coronary Artery Disease, decision-making agreement