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

The Effect of an Optimal Heart Team Implementation Protocol on the Stability of Decision-making for Complex Coronary Artery Disease-a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Behavioral: optimal heart team protocol

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 Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: optimal heart team group; 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; 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.
No Intervention: conventional heart team group; 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

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Principal Investigator: Zhe Zheng, MD,PhD, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2022
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: August 26, 2021
• First Submitted That Met QC Criteria: September 8, 2021
• First Posted (Actual): September 9, 2021

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Heart Team protocol; decision-making agreement
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 2019-1303-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No