Coronary Artery Disease
Conditions
Keywords
Heart Team protocol, Coronary Artery Disease, decision-making agreement
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.
Interventions
BEHAVIORALoptimal 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.
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
Countries
China
Outcome results
None listed