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

NCT ID: NCT07326514

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

1350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2028-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Real-time heart team group

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

Group Type EXPERIMENTAL

Real-Time Heart Team Decision-making

Intervention Type OTHER

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

Usual care group

An usual care decision-making initiated by interventional cardiologists will be conducted

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Real-Time Heart Team Decision-making

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

Fuwai Yunnan Cardiovascular Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role collaborator

Central China Fuwai Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role collaborator

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role collaborator

Shenzhen Sun Yat-sen Cardiovascular Hospital

OTHER

Sponsor Role collaborator

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Zhe Zheng, MD, PhD

Role: CONTACT

+86-88396051

Other Identifiers

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2025-2850

Identifier Type: -

Identifier Source: org_study_id

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