Feasibility and Effectiveness of a Real-time Heart Team Approach in Complex CAD

Study Overview
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Brief Summary
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This study is aimed to evaluate the clinical outcomes, efficiency and feasibility of the real-time heart team approach and the conventional heart team approach.

Detailed Description
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This study is a multicenter, randomized controlled trial. According to the inclusion and exclusion criteria, patients with complex coronary artery disease undergoing elective coronary angiography will be prospectively enrolled in the study. Patients will be randomly assigned to the real-time heart team group and the conventional heart team group by block randomization. The real-time heart team group needs to conduct multidisciplinary heart team discussion during the coronary angiography process, while the traditional heart team group needs to conduct multidisciplinary heart team discussion offline and face-to-face after the coronary angiography process. Patients who are not randomized will be registered. This study will prospectively collect the patient information, heart team meeting process, clinical treatment, and clinical outcomes to evaluate the efficiency and feasibility and differences in clinical outcomes of patients under different heart team approaches.

Official Title
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Feasibility and Effectiveness of a Real-time Heart Team Approach in Complex Coronary Artery Disease

Conditions
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Cardiovascular Diseases, Coronary Artery Disease, Multidisciplinary Communication

Intervention / Treatment
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* Behavioral: heart team meeting and discussion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Significant stenosis in the left main or left main equivalent with or without stenosis in one of the other vessels[Significant stenosis is defined as: 1) a diameter stenosis of at least 50% reduction in luminal diameter by visual assessment or 2) any total occlusion (no age limitation and no exclusion of unfavorable anatomic features); Left main equivalent disease is defined as significant stenosis of the ostium of the left anterior descending and the ostium of the left circumflex.] At least 1 significant stenosis in all 3 major epicardial territories supplying viable myocardium; Other conditions that the interventional cardiologist considers necessary to discuss with cardiac surgeons due to technical and risk considerations. Exclusion Criteria: Less than 18 years of age; Previous history of PCI or CABG; Admitted for AMI, ECG and biomarker detection indicated acute stage; Patients with severe heart valvular disease, major vascular disease, and giant ventricular aneurysm require surgical treatment; Combined with AF or severe arrhythmia; Other patients admitted to hospital due to emergency circumstances who are not suitable to wait for elective revascularization; Rejection or exclusion of a revascularization mode (PCI or CABG); Refuse to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: real-time heart team group<br>Patients randomized to this group will be accessed and discussed by multidisciplinary specialists during the coronary angiography process | Behavioral: heart team meeting and discussion<br>* When the patient is eligible for the study, the interventional cardiologist will invite a cardiac surgeon to conduct a heart team discussion. Both specialists will assess the patient comprehensively and make an optimal decision for the patient, with consideration patient's preference.<br>|
| Active Comparator: conventional heart team group<br>Patients randomized to this group will be accessed and discussed offline and face-to-face by multidisciplinary specialists after the coronary angiography process | Behavioral: heart team meeting and discussion<br>* When the patient is eligible for the study, the interventional cardiologist will invite a cardiac surgeon to conduct a heart team discussion. Both specialists will assess the patient comprehensively and make an optimal decision for the patient, with consideration patient's preference.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year major adverse cardiovascular and cerebrovascular events | a composite of all-cause death, myocardial infarction, stroke, repeated revascularization, ischemic symptoms with hospital admission. | At 1 year after the coronary angiography | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time interval between the completion of coronary angiography and the final treatment | time interval is considered as a key secondary outcome | through study completion, an average of 1 year | 
| the appropriateness rate of heart team decisions | assessment of the heart team dicision appropriateness according to Appropriateness Use Criteria and guidelines | through study completion, an average of 1 year | 
| heart team decision distribution | assessment of the heart team dicision distribution, such as the rate of CABG, PCI, and medical treatment | through study completion, an average of 1 year | 
| working load of organizing heart team meetings | to assess the work load of arganising heart team meetings by NASA-TLX | through study completion, an average of 1 year | 
| success rate of heart team organization | to assess the successful-connection with cardiac surgeons during or after the coronary angiography | through study completion, an average of 1 year | 
| time consuming of heart team discussions | to assess the time consuming of heart team organization and discussion during or after the coronary angiography | through study completion, an average of 1 year | 
| length of stay | to assess length of stay (LOS) before the final treatment, and the totol LOS in hospital | through study completion, an average of 1 year | 
| total cost | to assess the total cost in hospital for the initial hospitalization and rehospitalization | through study completion, an average of 3 year | 
| time interval of each diagnosis and treatment procedures | to assess the time consuming of the angiography to heart team meeting time and heart team meeting to final treatment time | through study completion, an average of 1 year | 
| individual clinical adverse events | including all-cause death, cardiac death, myocardial infarction, stroke, revascularization of target vessels or transplanted vessels, revascularization for any reason, be admitted to hospital with angina again, readmission for cardiac reasons and readmission for any reason | At 1 year after the coronary angiography |