Electronic Real-Time Heart Team Decision-making vs. Usual Care in Patients With Triple-Vessel Coronary Artery Disease and Diabetes Mellitus (EHEART-3VD)

This is a multi-center randomized controlled trial involving patients with 3-vessel coronary artery disease and diabetes mellitus. Enrolled patients will be dividing into real-time heart team decision-making group (intervention group) and usual care group (control group). The intervention group will conduct a real-time online multidisciplinary heart team discussion and decision-making during coronary angiography. The control group will conduct an usual care decision-making.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease; Diabetes
• Intervention / Treatment: Other: Real-Time Heart Team Decision-making

• Study Type: Interventional
• Enrollment (Estimated): 1350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhe Zheng, MD, PhD; Phone Number: +86-88396051; Email: zhengzhe@fuwai.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria (Fulfill 1,2,3 or 1,4):

1. Age ≥ 18 years;
2. Diabetes mellitus;
3. Three-vessel coronary artery disease (≥70% stenosis in the left anterior descending artery, circumflex artery, and right coronary artery system);
4. Patients who required heart team discussion judging by the interventional cardiologist.

Exclusion Criteria:

1. Prior PCI or CABG;
2. Acute myocardial infarction with ECG and biomarker tests indicating acute phase;
3. Concurrent severe valvular heart disease, large vessel disease, or giant ventricular aneurysm requiring surgical intervention;
4. Concurrent atrial fibrillation or severe arrhythmia;
5. Other emergency admissions where elective revascularization is contraindicated;
6. Refusal or rejection of a specific treatment options (PCI or CABG);
7. Refusal to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Real-time heart team group; A online multidisciplinary heart team discussion and decision-making will be conducted during angiography	Other: Real-Time Heart Team Decision-making; A online multidisciplinary heart team discussion and decision-making will be conducted during coronary angiography.
No Intervention: Usual care group; An usual care decision-making initiated by interventional cardiologists will be conducted

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
One-year composite of major adverse cardiac and cerebral events	One-year composite pf all-cause mortality, myocardial infarction, stroke, repeat revascularization, and rehospitalization for recurrent angina.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical adverse events	Incidence and time to first clinical event, including: all-cause mortality, cardiac mortality, non-fatal myocardial infarction, stroke, target-vessel or graft revascularization, repeat revascularization, unplanned revascularization, rehospitalization for recurrent angina, cardiac rehospitalization, and all-cause rehospitalization.	From randomization through 1-year follow-up (events recorded during index hospitalization and at follow-up visits up to 12 months).
Guideline-concordant revascularization decision rate	Proportion of coronary revascularization decisions that are concordant with the Guidelines class I or IIa recommendations.	During index hospitalization (typically within 30 days of admission)
Percutaneous coronary intervention (PCI) utilization rate	Proportion of patients who undergo PCI as part of their coronary revascularization strategy.	During index hospitalization (typically within 30 days of admission)
Coronary artery bypass grafting (CABG) utilization rate	Proportion of patients who undergo CABG as part of their coronary revascularization strategy.	During index hospitalization (typically within 30 days of admission)
Medical therapy rate	Proportion of patients managed with medical therapy.	During index hospitalization (typically within 30 days of admission)
Waiting time from diagnostic angiography to treatment initiation	Time from completion of diagnostic coronary angiography to initiation of the definitive treatment strategy (PCI, CABG, or medical therapy).	During index hospitalization (typically within 30 days of admission)
Medical costs	Medical costs during the index hospitalization.	Index hospitalization until discharge (typically within 30 days of admission).
Hospital length of stay	Number of days from hospital admission to hospital discharge for the index hospitalization.	From hospital admission to discharge for the index hospitalization (up to 30 days).
Prolonged PCI hospitalization	Proportion of patients with prolonged length of stay after PCI, defined according to the Centers for Medicare and Medicaid Services (CMS) criteria.	From index PCI procedure to discharge for the index hospitalization (up to 30 days).
Time spent per heart team case	Duration of each heart team discussion.	At the time of the heart team discussion during the index hospitalization (up to 30 days from admission).
Specialist satisfaction with discussion adequacy	Satisfaction of participating specialists (interventional cardiologists and cardiac surgeons) with the adequacy of the discussion, assessed using a numeric rating scale (0-10, higher scores indicating greater satisfaction); reported as mean (±SD) score per group.	Immediately after each heart team discussion during the index hospitalization (up to 30 days from admission).
Seniority of participating specialist in heart team discussions	Proportion of specialists with different seniority, such as associated chief, chief etc..	From index PCI procedure to discharge for the index hospitalization (up to 30 days)
Multidisciplinary synchronous shared decision-making	Proportion of cases in which interventional cardiology and cardiac surgery participate in a synchronous discussion with patient or relatives.	From index PCI procedure to discharge for the index hospitalization (up to 30 days)
Patient satisfaction with the decision-making process	Patient-reported satisfaction with the coronary revascularization decision-making process, assessed using a structured questionnaire with a 5-point Likert scale.	Within 24 hours before discharge from the index hospitalization (up to 30 days from admission).
Recatheterization rate	Repeat invasive coronary angiography after the index procedure.	During index hospitalization (typically within 30 days of admission)
Specialist workload	Workload of participating specialists based on NASA-TLX scale	During index hospitalization (typically within 30 days of admission)
Real-time consultation response rate	A real-time response from cardiac surgeon during the coronary angiography.	During index hospitalization (typically within 30 days of admission)

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Ruijin Hospital; Nanjing First Hospital, Nanjing Medical University; Chinese Academy of Medical Sciences, Fuwai Hospital; The First Affiliated Hospital of Dalian Medical University; Shenzhen Sun Yat-sen Cardiovascular Hospital; Fuwai Yunnan Cardiovascular Hospital; Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; Central China Fuwai Hospital of Zhengzhou University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: November 28, 2025
• First Submitted That Met QC Criteria: December 24, 2025
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: implementation science; coronary revascularization; heart team
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Nutritional and Metabolic Diseases; Diabetes Mellitus; Coronary Artery Disease
• Other Study ID Numbers: 2025-2850

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