Cardiovascular DiseasesEHEARTNCT05514210

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

A study testing heart team meeting and discussion in people with Cardiovascular Diseases and Coronary Artery Disease, run by China National Center for Cardiovascular Diseases at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Cardiovascular Diseases, Coronary Artery Disease, Multidisciplinary Communication
What is being tested?: heart team meeting and discussion
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 490 participants
Where: 1 siteChina
Study dates: 15 Sep 2023to 11 Jun 2025
Phase: Interventional
Are there results?: None posted in the registry

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 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.]
At least 1 significant stenosis (≥ 70% obstruction) in all 3 major epicardial territories supplying viable myocardium;
Other conditions that the interventional cardiologist considers necessary to discuss with cardiac surgeons due to technical and risk considerations.

Who cannot join

Less than 18 years of age;
Previous history of PCI or CABG;
Admitted for AMI, ECG and biomarker detection indicated acute stage;
Patients with severe heart valvular disease, major vascular disease, and giant ventricular aneurysm require surgical treatment;
Combined with AF or severe arrhythmia;
Other patients admitted to hospital due to emergency circumstances who are not suitable to wait for elective revascularization;
Rejection or exclusion of a revascularization mode (PCI or CABG);
Refuse to participate in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

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

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions: Cardiovascular Diseases, Coronary Artery Disease, Multidisciplinary Communication
Being tested: heart team meeting and discussion
Keywords: Complex coronary artery disease, Revascularization decision-making, Heart team process optimization
Medical subject headings: Cardiovascular Diseases, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

heart team meeting and discussionBehavioural
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.

Study groups in NCT05514210
Study group	Role	What they receive
real-time heart team group	Experimental	Patients randomized to this group will be accessed and discussed by multidisciplinary specialists during the coronary angiography process Receives: Behavioral: heart team meeting and discussion
conventional heart team group	Active comparator	Patients randomized to this group will be accessed and discussed offline and face-to-face by multidisciplinary specialists after the coronary angiography process Receives: Behavioral: heart team meeting and discussion

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (9)

time interval between the completion of coronary angiography and the final treatment
time interval is considered as a key secondary outcome
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: through study completion, an average of 1 year
success rate of heart team organization
to assess the successful-connection with cardiac surgeons during or after the coronary angiography
Measured: 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
Measured: through study completion, an average of 1 year
total cost
to assess the total cost in hospital for the initial hospitalization and rehospitalization
Measured: 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
Measured: At 1 year after the coronary angiography

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Sep 202311 Jun 2025

First posted24 Aug 2022
Study start15 Sep 2023
Primary completion21 May 2025
Study completion11 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 490 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05514210
Sponsor's protocol ID: 2022-1749
Acronym: EHEART
Status last verified: Jul 2025
First submitted: 22 Aug 2022
Last updated: 30 Jul 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Lin S, Su X, Ma H, Dou K, Song L, Zhao H, Qian J, Liu S, Xu F, Wang X, Yang Y, Su P, Jin Z, Wang Y, Zheng Z. Real-Time Heart Team for Revascularization in Complex Coronary Artery Disease: The EHEART Randomized Trial. J Am Coll Cardiol. 2026 Jun 23;87(24):3467-3479. doi: 10.1016/j.jacc.2026.01.010. Epub 2026 Mar 4.
PubMed 41778947
Su X, Ma H, Lin S, Dou K, Zheng Z. Safety and feasibility of a real-time electronic heart team decision-making approach in patients with complex coronary artery disease: a protocol for a randomised controlled trial (EHEART trial). BMJ Open. 2023 Nov 21;13(11):e076864. doi: 10.1136/bmjopen-2023-076864.
PubMed 37989362

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility and Effectiveness of a Real-time Heart Team Approach in Complex Coronary Artery Disease
ClinicalTrials.gov ID: NCT05514210
Acronym / sponsor ID: EHEART / 2022-1749
Conditions: Cardiovascular Diseases, Coronary Artery Disease, Multidisciplinary Communication
Keywords: Complex coronary artery disease, Revascularization decision-making, Heart team process optimization
Study type: Interventional
Recruitment status: Completed
Enrolment: 490 participants (actual)
Lead sponsor: China National Center for Cardiovascular DiseasesOther government
Study start: 15 Sep 2023 (actual)
Primary completion: 21 May 2025 (actual)
Study completion: 11 Jun 2025 (actual)
First posted: 24 Aug 2022 (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 study is aimed to evaluate the clinical outcomes, efficiency and feasibility of the real-time heart team approach and the conventional heart team approach.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
real-time heart team group	Experimental	Behavioral: heart team meeting and discussionPatients randomized to this group will be accessed and discussed by multidisciplinary specialists during the coronary angiography process
conventional heart team group	Active comparator	Behavioral: heart team meeting and discussionPatients randomized to this group will be accessed and discussed offline and face-to-face by multidisciplinary specialists after the coronary angiography process

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.]
At least 1 significant stenosis (≥ 70% obstruction) in all 3 major epicardial territories supplying viable myocardium;
Other conditions that the interventional cardiologist considers necessary to discuss with cardiac surgeons due to technical and risk considerations.

Key exclusion criteria (8 listed)

Less than 18 years of age;
Previous history of PCI or CABG;
Admitted for AMI, ECG and biomarker detection indicated acute stage;
Patients with severe heart valvular disease, major vascular disease, and giant ventricular aneurysm require surgical treatment;
Combined with AF or severe arrhythmia;

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
heart team meeting and discussionWhen 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.	Behavioural	conventional heart team group, real-time heart team group

Primary outcome

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

9 secondary outcomes

time interval between the completion of coronary angiography and the final treatment
Time frame: through treatment completion, an average of 60 days
revascularization decision-making
Time frame: through study completion, an average of 1 year
revascularization decision-making guideline adherence
Time frame: through study completion, an average of 1 year
heart team decision-making
Time frame: through study completion, an average of 1 year
workload of heart team specialists
Time frame: through study completion, an average of 1 year
success rate of heart team organization
Time frame: through study completion, an average of 1 year
length of stay
Time frame: through study completion, an average of 1 year
total cost
Time frame: through study completion, an average of 3 year
individual clinical adverse events
Time frame: At 1 year after the coronary angiography

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
Derived from this study: PubMed 41778947Lin S, Su X, Ma H, Dou K, Song L, Zhao H, Qian J, Liu S, Xu F, Wang X, Yang Y, Su P, Jin Z, Wang Y, Zheng Z. Real-Time Heart Team for Revascularization in Complex Coronary Artery Disease: The EHEART Randomized Trial. J Am Coll Cardiol. 2026 Jun 23;87(24):3467-3479. doi: 10.1016/j.jacc.2026.01.010. Epub 2026 Mar 4.
Derived from this study: PubMed 37989362Su X, Ma H, Lin S, Dou K, Zheng Z. Safety and feasibility of a real-time electronic heart team decision-making approach in patients with complex coronary artery disease: a protocol for a randomised controlled trial (EHEART trial). BMJ Open. 2023 Nov 21;13(11):e076864. doi: 10.1136/bmjopen-2023-076864.
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. This study is not recruiting at the moment.

Zhe Zheng, MD,PhD principal investigator

Chinese Academy of Medical Sciences, Fuwai Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing heart team meeting and discussion in people with Cardiovascular Diseases and Coronary Artery Disease, run by China National Center for Cardiovascular Diseases at 1 site in China.

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 3 inclusion and 8 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: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-year major adverse cardiovascular and cerebrovascular events (time frame: At 1 year after the coronary angiography). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05514210, which also lists 2 linked publications.

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 30 Jul 2025.