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

NCT05514210 | Completed DMC

• 1 other identifier: 2022-1749
• Study Type: interventional
• Target: 490
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Diseases; Coronary Artery Disease; Multidisciplinary Communication

Keywords

Complex coronary artery disease; Revascularization decision-making; Heart team process optimization

Outcome Measures

Primary Outcomes (1)

• 1-year major adverse cardiovascular and cerebrovascular events

  a composite of all-cause mortality, myocardial infarction, stroke, unplanned revascularization, readmission due to reangina.

  At 1 year after the coronary angiography

Secondary Outcomes (9)

• time interval between the completion of coronary angiography and the final treatment

  through treatment completion, an average of 60 days

• revascularization decision-making

  through study completion, an average of 1 year

• revascularization decision-making guideline adherence

  through study completion, an average of 1 year

• heart team decision-making

  through study completion, an average of 1 year

• workload of heart team specialists

  through study completion, an average of 1 year

Study Arms (2)

real-time heart team group

EXPERIMENTAL

Patients randomized to this group will be accessed and discussed by multidisciplinary specialists during the coronary angiography process

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

Behavioral: heart team meeting and discussion

Interventions

heart team meeting and discussion BEHAVIORAL

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.

conventional heart team group; real-time heart team group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Refuse to participate in the study.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

China National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (1)

• 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.

  PMID: 37989362 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Zhe Zheng, MD,PhD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 24, 2022
• Study Start: September 15, 2023
• Primary Completion: May 21, 2025
• Study Completion: June 11, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)