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

Feasibility and Effectiveness of a Real-time Heart Team Approach in Complex Coronary Artery Disease

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Coronary Artery Disease; Multidisciplinary Communication
• Intervention / Treatment: Behavioral: heart team meeting and discussion

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 Type: Interventional
• Enrollment (Actual): 490
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • China National Center for Cardiovascular Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: real-time heart team group; Patients randomized to this group will be accessed and discussed by multidisciplinary specialists during the coronary angiography process	Behavioral: 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.
Active Comparator: 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	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-year major adverse cardiovascular and cerebrovascular events	a composite of all-cause mortality, myocardial infarction, stroke, unplanned revascularization, readmission due to reangina.	At 1 year after the coronary angiography

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
success rate of heart team organization	to assess the successful-connection with cardiac surgeons during or after the coronary angiography	through study completion, an average of 1 year
length of stay	to assess length of stay (LOS) before the final treatment, and the totol LOS in hospital	through study completion, an average of 1 year
total cost	to assess the total cost in hospital for the initial hospitalization and rehospitalization	through study completion, an average of 3 year
individual clinical adverse events	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	At 1 year after the coronary angiography
time interval between the completion of coronary angiography and the final treatment	time interval is considered as a key secondary outcome	through treatment completion, an average of 60 days
revascularization decision-making	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	through study completion, an average of 1 year
revascularization decision-making guideline adherence	adjudicated according to 2018 European Society of Cardiology (ESC)/ European Association for Cardio-Thoracic Surgery (EACTS) guideline	through study completion, an average of 1 year
heart team decision-making	to assess the distribution of the decision-making made by the heart team, such as CABG, PCI or medical therapy	through study completion, an average of 1 year
workload of heart team specialists	to assess the workload of the specialists participating in the heart team meetings by NASA-TLX scale	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Principal Investigator: Zhe Zheng, MD,PhD, Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Actual): May 21, 2025
• Study Completion (Actual): June 11, 2025

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 22, 2022
• First Posted (Actual): August 24, 2022

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 25, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Complex coronary artery disease; Revascularization decision-making; Heart team process optimization
• Additional Relevant MeSH Terms: Vascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 2022-1749

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No