Feasibility and Effectiveness of a Real-time Heart Team Approach in Complex CAD
- Conditions
- Coronary Artery DiseaseMultidisciplinary CommunicationCardiovascular Diseases
- Interventions
- Behavioral: heart team meeting and discussion
- Registration Number
- NCT05514210
- Lead Sponsor
- China National Center for Cardiovascular Diseases
- 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. 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 490
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description conventional heart team group heart team meeting and discussion Patients randomized to this group will be accessed and discussed offline and face-to-face by multidisciplinary specialists after the coronary angiography process real-time heart team group heart team meeting and discussion Patients randomized to this group will be accessed and discussed by multidisciplinary specialists during the coronary angiography process
- Primary Outcome Measures
Name Time Method 1-year major adverse cardiovascular and cerebrovascular events At 1 year after the coronary angiography a composite of all-cause death, myocardial infarction, stroke, repeated revascularization, ischemic symptoms with hospital admission.
- Secondary Outcome Measures
Name Time Method time interval between the completion of coronary angiography and the final treatment through study completion, an average of 1 year time interval is considered as a key secondary outcome
the appropriateness rate of heart team decisions through study completion, an average of 1 year assessment of the heart team dicision appropriateness according to Appropriateness Use Criteria and guidelines
time consuming of heart team discussions through study completion, an average of 1 year to assess the time consuming of heart team organization and discussion during or after the coronary angiography
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
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
heart team decision distribution through study completion, an average of 1 year assessment of the heart team dicision distribution, such as the rate of CABG, PCI, and medical treatment
total cost through study completion, an average of 3 year to assess the total cost in hospital for the initial hospitalization and rehospitalization
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
working load of organizing heart team meetings through study completion, an average of 1 year to assess the work load of arganising heart team meetings by NASA-TLX
time interval of each diagnosis and treatment procedures through study completion, an average of 1 year to assess the time consuming of the angiography to heart team meeting time and heart team meeting to final treatment time
Trial Locations
- Locations (1)
China National Center for Cardiovascular Diseases
🇨🇳Beijing, Beijing, China