DiabetesEHEART-3VDNCT07326514
Electronic Real-Time Heart Team Decision-making vs. Usual Care in Patients With Triple-Vessel Coronary Artery Disease and Diabetes Mellitus
A study testing Real-Time Heart Team Decision-making in people with Diabetes and Coronary Artery Disease, run by China National Center for Cardiovascular Diseases.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Coronary Artery Disease
- What is being tested?
- Real-Time Heart Team Decision-making
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,350 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Diabetes, Coronary Artery Disease
- Being tested
- Real-Time Heart Team Decision-making
- Keywords
- coronary revascularization, heart team, implementation science
- Medical subject headings
- Diabetes Mellitus, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-Time Heart Team Decision-makingOther
A online multidisciplinary heart team discussion and decision-making will be conducted during coronary angiography.
| Study group | Role | What they receive |
|---|---|---|
| Real-time heart team group | Experimental | A online multidisciplinary heart team discussion and decision-making will be conducted during angiography Receives: Other: Real-Time Heart Team Decision-making |
| Usual care group | No intervention | An usual care decision-making initiated by interventional cardiologists will be conducted |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During index hospitalization (typically within 30 days of admission)
Medical therapy rate
Proportion of patients managed with medical therapy.
Measured: 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).
Measured: During index hospitalization (typically within 30 days of admission)
Medical costs
Medical costs during the index hospitalization.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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..
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During index hospitalization (typically within 30 days of admission)
Specialist workload
Workload of participating specialists based on NASA-TLX scale
Measured: 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.
Measured: During index hospitalization (typically within 30 days of admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital, The First Affiliated Hospital of Dalian Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Fuwai Yunnan Cardiovascular Hospital, The First Affiliated Hospital with Nanjing Medical University, Central China Fuwai Hospital of Zhengzhou University, Ruijin Hospital, Nanjing First Hospital, Nanjing Medical University, Shenzhen Sun Yat-sen Cardiovascular Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326514
- Sponsor's protocol ID
- 2025-2850
- Acronym
- EHEART-3VD
- Status last verified
- Dec 2025
- First submitted
- 28 Nov 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Real-Time Heart Team Decision-making vs. Usual Care in Patients With Triple-Vessel Coronary Artery Disease and Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07326514
- Acronym / sponsor ID
- EHEART-3VD / 2025-2850
- Conditions
- Diabetes, Coronary Artery Disease
- Keywords
- coronary revascularization, heart team, implementation science
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,350 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital, The First Affiliated Hospital of Dalian Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Fuwai Yunnan Cardiovascular Hospital, The First Affiliated Hospital with Nanjing Medical University, Central China Fuwai Hospital of Zhengzhou University, Ruijin Hospital, Nanjing First Hospital, Nanjing Medical University, Shenzhen Sun Yat-sen Cardiovascular Hospital
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real-time heart team group | Experimental | Other: Real-Time Heart Team Decision-makingA online multidisciplinary heart team discussion and decision-making will be conducted during angiography |
| Usual care group | No intervention | –An usual care decision-making initiated by interventional cardiologists will be conducted |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-Time Heart Team Decision-makingA online multidisciplinary heart team discussion and decision-making will be conducted during coronary angiography. | Other | Real-time heart team group |
Primary outcome
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.
17 secondary outcomes
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).
Guideline-concordant revascularization decision rate
Time frame: 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)
Coronary artery bypass grafting (CABG) utilization rate
Time frame: During index hospitalization (typically within 30 days of admission)
Medical therapy rate
Time frame: 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)
Medical costs
Time frame: 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).
Prolonged PCI hospitalization
Time frame: 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).
Specialist satisfaction with discussion adequacy
Time frame: 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)
Multidisciplinary synchronous shared decision-making
Time frame: 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).
Recatheterization rate
Time frame: During index hospitalization (typically within 30 days of admission)
Specialist workload
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Real-Time Heart Team Decision-making in people with Diabetes and Coronary Artery Disease, run by China National Center for Cardiovascular Diseases.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhe Zheng, MD, PhD (+86-88396051, zhengzhe@fuwai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-year composite of major adverse cardiac and cerebral events (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.