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

National Center for Cardiovascular Diseases

Status: Completed

Conditions: Coronary Artery Disease; Multidisciplinary Communication; Cardiovascular Diseases

Treatments: Behavioral: heart team meeting and discussion

Study type: Interventional

Funder types: Other

Identifiers

NCT05514210

2022-1749

Details and patient eligibility

About

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.

Full 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.

Enrollment: 490 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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490 participants in 2 patient groups

real-time heart team group

Experimental group

Description:

Patients randomized to this group will be accessed and discussed by multidisciplinary specialists during the coronary angiography process

Treatment:

Behavioral: heart team meeting and discussion

conventional heart team group

Active Comparator group

Description:

Patients randomized to this group will be accessed and discussed offline and face-to-face by multidisciplinary specialists after the coronary angiography process

Treatment:

Behavioral: heart team meeting and discussion