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

December 24, 2025 updated by: China National Center for Cardiovascular Diseases
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1350

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
During index hospitalization (typically within 30 days of admission)
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.
During index hospitalization (typically within 30 days of admission)
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.
During index hospitalization (typically within 30 days of admission)
Medical therapy rate
Time Frame: During index hospitalization (typically within 30 days of admission)
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 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).
During index hospitalization (typically within 30 days of admission)
Medical costs
Time Frame: Index hospitalization until discharge (typically within 30 days of admission).
Medical costs during the index hospitalization.
Index hospitalization until discharge (typically within 30 days of admission).
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.
From hospital admission to discharge for the index hospitalization (up to 30 days).
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.
From index PCI procedure to discharge for the index hospitalization (up to 30 days).
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.
At the time of the heart team discussion during the index hospitalization (up to 30 days from admission).
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.
Immediately after each heart team discussion during the index hospitalization (up to 30 days from admission).
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..
From index PCI procedure to discharge for the index hospitalization (up to 30 days)
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.
From index PCI procedure to discharge for the index hospitalization (up to 30 days)
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.
Within 24 hours before discharge from the index hospitalization (up to 30 days from admission).
Recatheterization rate
Time Frame: During index hospitalization (typically within 30 days of admission)
Repeat invasive coronary angiography after the index procedure.
During index hospitalization (typically within 30 days of admission)
Specialist workload
Time Frame: During index hospitalization (typically within 30 days of admission)
Workload of participating specialists based on NASA-TLX scale
During index hospitalization (typically within 30 days of admission)
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.
During index hospitalization (typically within 30 days of admission)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China National Center for Cardiovascular Diseases

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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