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Not yet recruiting NCT07326514

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

No phase Interventional Diabetes Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Real-Time Heart Team Decision-making.
Who it may be relevant to
Registry conditions: Diabetes, Coronary Artery Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other Real-Time Heart Team Decision-making
    A online multidisciplinary heart team discussion and decision-making will be conducted during coronary angiography.

Primary outcome measures

  • One-year composite of major adverse cardiac and cerebral events [Time frame: 1 year]
Secondary outcome measures (12)
  • 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)]

Eligibility criteria

Inclusion Criteria (Fulfill 1,2,3 or 1,4):

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07326514 · 2025-2850

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗