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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05039567
• Other study ID #: 2019-1303-2
• Status: Completed
• Phase: N/A
• Start date: January 4, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: October 2022
• Source: China National Center for Cardiovascular Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: February 28, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Behavioral:
• optimal heart team protocol
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.

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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