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

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Behavioral: optimal heart team protocol

• Registration Number: NCT05039567
• Lead Sponsor: China National Center for Cardiovascular Diseases

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.

Study Timeline

• Study First Submitted: 2021-08-26
• Study First Submitted QC: 2021-09-08
• Study First Posted: 2021-09-09
• Study Start: 2022-01-04
• Status Verified: 2022-10
• Primary Completion: 2022-12-30
• Study Completion: 2023-02-28
• Last Update Submitted: 2023-03-29
• Last Update Posted: 2023-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
optimal heart team group	optimal heart team protocol	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.

Primary Outcome Measures

Name	Time	Method
Overall percent agreement	through study completion, an average of 1 year	The proportion of patients who received unanimous decision recommendations from the heart team

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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; 🇨🇳 Beijing, Beijing, China