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NCT Number: NCT07326514

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

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.

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Key information

Conditions

Diabetes Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Exclusion criteria

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

Treatment and study plan

Real-Time Heart Team Decision-making

Other

A online multidisciplinary heart team discussion and decision-making will be conducted during coronary angiography.

Primary outcomes

  1. One-year composite of major adverse cardiac and cerebral events

    Time frame: 1 year

    One-year composite pf all-cause mortality, myocardial infarction, stroke, repeat revascularization, and rehospitalization for recurrent angina.

Secondary outcomes

  1. Clinical adverse events

    Time frame: From randomization through 1-year follow-up (events recorded during index hospitalization and at follow-up visits up to 12 months).

    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.

  2. Guideline-concordant revascularization decision rate

    Time frame: During index hospitalization (typically within 30 days of admission)

    Proportion of coronary revascularization decisions that are concordant with the Guidelines class I or IIa recommendations.

  3. Percutaneous coronary intervention (PCI) utilization rate

    Time frame: During index hospitalization (typically within 30 days of admission)

    Proportion of patients who undergo PCI as part of their coronary revascularization strategy.

  4. Coronary artery bypass grafting (CABG) utilization rate

    Time frame: During index hospitalization (typically within 30 days of admission)

    Proportion of patients who undergo CABG as part of their coronary revascularization strategy.

  5. Medical therapy rate

    Time frame: During index hospitalization (typically within 30 days of admission)

    Proportion of patients managed with medical therapy.

  6. Waiting time from diagnostic angiography to treatment initiation

    Time frame: During index hospitalization (typically within 30 days of admission)

    Time from completion of diagnostic coronary angiography to initiation of the definitive treatment strategy (PCI, CABG, or medical therapy).

  7. Medical costs

    Time frame: Index hospitalization until discharge (typically within 30 days of admission).

    Medical costs during the index hospitalization.

  8. Hospital length of stay

    Time frame: From hospital admission to discharge for the index hospitalization (up to 30 days).

    Number of days from hospital admission to hospital discharge for the index hospitalization.

  9. Prolonged PCI hospitalization

    Time frame: From index PCI procedure to discharge for the index hospitalization (up to 30 days).

    Proportion of patients with prolonged length of stay after PCI, defined according to the Centers for Medicare and Medicaid Services (CMS) criteria.

  10. Time spent per heart team case

    Time frame: At the time of the heart team discussion during the index hospitalization (up to 30 days from admission).

    Duration of each heart team discussion.

  11. Specialist satisfaction with discussion adequacy

    Time frame: Immediately after each heart team discussion during the index hospitalization (up to 30 days from admission).

    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.

  12. Seniority of participating specialist in heart team discussions

    Time frame: From index PCI procedure to discharge for the index hospitalization (up to 30 days)

    Proportion of specialists with different seniority, such as associated chief, chief etc..

  13. Multidisciplinary synchronous shared decision-making

    Time frame: From index PCI procedure to discharge for the index hospitalization (up to 30 days)

    Proportion of cases in which interventional cardiology and cardiac surgery participate in a synchronous discussion with patient or relatives.

  14. Patient satisfaction with the decision-making process

    Time frame: Within 24 hours before discharge from the index hospitalization (up to 30 days from admission).

    Patient-reported satisfaction with the coronary revascularization decision-making process, assessed using a structured questionnaire with a 5-point Likert scale.

  15. Recatheterization rate

    Time frame: During index hospitalization (typically within 30 days of admission)

    Repeat invasive coronary angiography after the index procedure.

  16. Specialist workload

    Time frame: During index hospitalization (typically within 30 days of admission)

    Workload of participating specialists based on NASA-TLX scale

  17. Real-time consultation response rate

    Time frame: During index hospitalization (typically within 30 days of admission)

    A real-time response from cardiac surgeon during the coronary angiography.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhe Zheng, MD, PhD

CONTACT

[email protected]

+86-88396051

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Collaborators

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

Registry information

Acronym: EHEART-3VD

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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