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

NCT ID: NCT05514210

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 490 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2025-06-11

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.

Conditions

Cardiovascular Diseases; Coronary Artery Disease; Multidisciplinary Communication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

real-time heart team group

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

Group Type: EXPERIMENTAL

heart team meeting and discussion

Intervention Type: BEHAVIORAL

When the patient is eligible for the study, the interventional cardiologist will invite a cardiac surgeon to conduct a heart team discussion. Both specialists will assess the patient comprehensively and make an optimal decision for the patient, with consideration patient's preference.

conventional heart team group

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

Group Type: ACTIVE_COMPARATOR

heart team meeting and discussion

Intervention Type: BEHAVIORAL

When the patient is eligible for the study, the interventional cardiologist will invite a cardiac surgeon to conduct a heart team discussion. Both specialists will assess the patient comprehensively and make an optimal decision for the patient, with consideration patient's preference.

Interventions

heart team meeting and discussion

When the patient is eligible for the study, the interventional cardiologist will invite a cardiac surgeon to conduct a heart team discussion. Both specialists will assess the patient comprehensively and make an optimal decision for the patient, with consideration patient's preference.

Intervention Type: BEHAVIORAL

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 (≥ 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhe Zheng, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Locations

China National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, China

Countries

China

References

Su X, Ma H, Lin S, Dou K, Zheng Z. Safety and feasibility of a real-time electronic heart team decision-making approach in patients with complex coronary artery disease: a protocol for a randomised controlled trial (EHEART trial). BMJ Open. 2023 Nov 21;13(11):e076864. doi: 10.1136/bmjopen-2023-076864.

Reference Type: DERIVED

PMID: 37989362 (View on PubMed)

Other Identifiers

2022-1749

Identifier Type: -

Identifier Source: org_study_id