Feasibility and Effectiveness of a Real-time Heart Team Approach in Complex Coronary Artery Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular Diseases
- Sponsor
- China National Center for Cardiovascular Diseases
- Enrollment
- 490
- Locations
- 1
- Primary Endpoint
- 1-year major adverse cardiovascular and cerebrovascular events
- Status
- Completed
- Last Updated
- 9 months ago
Overview
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.
Investigators
Eligibility Criteria
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 (≥ 70% obstruction) 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.
Outcomes
Primary Outcomes
1-year major adverse cardiovascular and cerebrovascular events
Time Frame: At 1 year after the coronary angiography
a composite of all-cause mortality, myocardial infarction, stroke, unplanned revascularization, readmission due to reangina.
Secondary Outcomes
- revascularization decision-making guideline adherence(through study completion, an average of 1 year)
- individual clinical adverse events(At 1 year after the coronary angiography)
- workload of heart team specialists(through study completion, an average of 1 year)
- revascularization decision-making(through study completion, an average of 1 year)
- total cost(through study completion, an average of 3 year)
- time interval between the completion of coronary angiography and the final treatment(through treatment completion, an average of 60 days)
- heart team decision-making(through study completion, an average of 1 year)
- success rate of heart team organization(through study completion, an average of 1 year)
- length of stay(through study completion, an average of 1 year)