Clinical trial NCT05514210: Feasibility and Effectiveness of a Real-time Heart Team Approach in Complex CAD
Official title: Feasibility and Effectiveness of a Real-time Heart Team Approach in Complex Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Diseases
Coronary Artery Disease
Multidisciplinary Communication
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2022-08-24
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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 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.

Primary outcomes:
measure: 1-year major adverse cardiovascular and cerebrovascular events
timeFrame: At 1 year after the coronary angiography
Secondary outcomes:
measure: time interval between the completion of coronary angiography and the final treatment
timeFrame: through study completion, an average of 1 year
measure: the appropriateness rate of heart team decisions
timeFrame: through study completion, an average of 1 year
measure: heart team decision distribution
timeFrame: through study completion, an average of 1 year
measure: working load of organizing heart team meetings
timeFrame: through study completion, an average of 1 year
measure: success rate of heart team organization
timeFrame: through study completion, an average of 1 year
measure: time consuming of heart team discussions
timeFrame: through study completion, an average of 1 year
measure: length of stay
timeFrame: through study completion, an average of 1 year
measure: total cost
timeFrame: through study completion, an average of 3 year
measure: time interval of each diagnosis and treatment procedures
timeFrame: through study completion, an average of 1 year
measure: individual clinical adverse events
timeFrame: At 1 year after the coronary angiography
Other outcomes:
Locations:
city: Beijing
country: China
facility: China National Center for Cardiovascular Diseases
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Zhe Zheng, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: