NCT07326514

Brief 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). 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,350

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
25mo left

Started Jan 2026

Typical duration for not_applicable diabetes

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Jan 2026Jun 2028

First Submitted

Initial submission to the registry

November 28, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

January 8, 2026

Status Verified

December 1, 2025

Enrollment Period

2.4 years

First QC Date

November 28, 2025

Last Update Submit

December 24, 2025

Conditions

DiabetesCoronary Artery Disease

Keywords

coronary revascularizationheart teamimplementation science

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Secondary Outcomes (17)

  • Clinical adverse events

    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

    During index hospitalization (typically within 30 days of admission)

  • Percutaneous coronary intervention (PCI) utilization rate

    During index hospitalization (typically within 30 days of admission)

  • Coronary artery bypass grafting (CABG) utilization rate

    During index hospitalization (typically within 30 days of admission)

  • Medical therapy rate

    During index hospitalization (typically within 30 days of admission)

  • +12 more secondary outcomes

Study Arms (2)

Real-time heart team group

EXPERIMENTAL

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

Other: Real-Time Heart Team Decision-making

Usual care group

NO INTERVENTION

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

Interventions

Real-Time Heart Team Decision-makingOTHER

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

Real-time heart team group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes MellitusCoronary Artery Disease

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Zhe Zheng, MD, PhD

CONTACT

+86-88396051zhengzhe@fuwai.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2025

First Posted

January 8, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

January 8, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share