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

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Multidisciplinary Communication; Cardiovascular Diseases

• 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. 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.

Study Timeline

• Study First Submitted: 2022-08-22
• Study First Submitted QC: 2022-08-22
• Study First Posted: 2022-08-24
• Study Start: 2023-09-15
• Primary Completion: 2025-05-21
• Study Completion: 2025-06-11
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-25
• Last Update Posted: 2025-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 490

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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 mortality, myocardial infarction, stroke, unplanned revascularization, readmission due to reangina.

Secondary Outcome Measures

Name	Time	Method
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
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
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
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
total cost	through study completion, an average of 3 year	to assess the total cost in hospital for the initial hospitalization and rehospitalization
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
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
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
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

Trial Locations

Locations (1)

China National Center for Cardiovascular Diseases; 🇨🇳 Beijing, Beijing, China