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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• One-year composite of major adverse cardiac and cerebral events [Срок оценки: 1 year]

Вторичные конечные точки (12)

• Clinical adverse events [Срок оценки: 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 [Срок оценки: During index hospitalization (typically within 30 days of admission)]
• Percutaneous coronary intervention (PCI) utilization rate [Срок оценки: During index hospitalization (typically within 30 days of admission)]
• Coronary artery bypass grafting (CABG) utilization rate [Срок оценки: During index hospitalization (typically within 30 days of admission)]
• Medical therapy rate [Срок оценки: During index hospitalization (typically within 30 days of admission)]
• Waiting time from diagnostic angiography to treatment initiation [Срок оценки: During index hospitalization (typically within 30 days of admission)]
• Medical costs [Срок оценки: Index hospitalization until discharge (typically within 30 days of admission).]
• Hospital length of stay [Срок оценки: From hospital admission to discharge for the index hospitalization (up to 30 days).]
• Prolonged PCI hospitalization [Срок оценки: From index PCI procedure to discharge for the index hospitalization (up to 30 days).]
• Time spent per heart team case [Срок оценки: At the time of the heart team discussion during the index hospitalization (up to 30 days from admission).]
• Specialist satisfaction with discussion adequacy [Срок оценки: Immediately after each heart team discussion during the index hospitalization (up to 30 days from admission).]
• Seniority of participating specialist in heart team discussions [Срок оценки: From index PCI procedure to discharge for the index hospitalization (up to 30 days)]

Критерии участия

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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07326514 · 2025-2850

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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