Cardiovascular Diseases, Coronary Artery Disease, Multidisciplinary Communication
Conditions
Keywords
Complex coronary artery disease, Revascularization decision-making, Heart team process optimization
Brief summary
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
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. 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.
Interventions
BEHAVIORALheart team meeting and discussion
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.
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Significant stenosis in the left main or left main equivalent with or without stenosis in one of the other vessels\[Significant stenosis is defined as: 1) a diameter stenosis of at least 50% reduction in luminal diameter by visual assessment or 2) any total occlusion (no age limitation and no exclusion of unfavorable anatomic features); Left main equivalent disease is defined as significant stenosis of the ostium of the left anterior descending and the ostium of the left circumflex.\] 2. At least 1 significant stenosis (≥ 70% obstruction) in all 3 major epicardial territories supplying viable myocardium; 3. Other conditions that the interventional cardiologist considers necessary to discuss with cardiac surgeons due to technical and risk considerations.
Exclusion criteria
1. Less than 18 years of age; 2. Previous history of PCI or CABG; 3. Admitted for AMI, ECG and biomarker detection indicated acute stage; 4. Patients with severe heart valvular disease, major vascular disease, and giant ventricular aneurysm require surgical treatment; 5. Combined with AF or severe arrhythmia; 6. Other patients admitted to hospital due to emergency circumstances who are not suitable to wait for elective revascularization; 7. Rejection or exclusion of a revascularization mode (PCI or CABG); 8. Refuse to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-year major adverse cardiovascular and cerebrovascular events | At 1 year after the coronary angiography | a composite of all-cause mortality, myocardial infarction, stroke, unplanned revascularization, readmission due to reangina. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| revascularization decision-making | through study completion, an average of 1 year | to assess the distribution of the revascularization decision-making made jointly by the heart team and the patients, such as CABG, PCI or medical therapy |
| revascularization decision-making guideline adherence | through study completion, an average of 1 year | adjudicated according to 2018 European Society of Cardiology (ESC)/ European Association for Cardio-Thoracic Surgery (EACTS) guideline |
| heart team decision-making | through study completion, an average of 1 year | to assess the distribution of the decision-making made by the heart team, such as CABG, PCI or medical therapy |
| workload of heart team specialists | through study completion, an average of 1 year | to assess the workload of the specialists participating in the heart team meetings by NASA-TLX scale |
| time interval between the completion of coronary angiography and the final treatment | through treatment completion, an average of 60 days | time interval is considered as a key secondary outcome |
| length of stay | through study completion, an average of 1 year | to assess length of stay (LOS) before the final treatment, and the totol LOS in hospital |
| total cost | through study completion, an average of 3 year | to assess the total cost in hospital for the initial hospitalization and rehospitalization |
| individual clinical adverse events | At 1 year after the coronary angiography | 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 |
| success rate of heart team organization | through study completion, an average of 1 year | to assess the successful-connection with cardiac surgeons during or after the coronary angiography |
Countries
China
Outcome results
None listed