NCT07326514尚未招募不适用
Electronic Real-Time Heart Team Decision-making vs. Usual Care in Patients With Triple-Vessel Coronary Artery Disease and Diabetes Mellitus
China National Center for Cardiovascular Diseases0 个研究点目标入组 1,350 人开始时间: 2026年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,350
- 主要终点
- One-year composite of major adverse cardiac and cerebral events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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.
排除标准
- •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.
结局指标
主要结局
One-year composite of major adverse cardiac and cerebral events
时间窗: 1 year
One-year composite pf all-cause mortality, myocardial infarction, stroke, repeat revascularization, and rehospitalization for recurrent angina.
次要结局
- Percutaneous coronary intervention (PCI) utilization rate(During index hospitalization (typically within 30 days of admission))
- Medical costs(Index hospitalization until discharge (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))
- Waiting time from diagnostic angiography to treatment initiation(During index hospitalization (typically within 30 days of admission))
- Hospital length of stay(From hospital admission to discharge for the index hospitalization (up to 30 days).)
- Prolonged PCI hospitalization(From index PCI procedure to discharge for the index hospitalization (up to 30 days).)
- Time spent per heart team case(At the time of the heart team discussion during the index hospitalization (up to 30 days from admission).)
- Specialist satisfaction with discussion adequacy(Immediately after each heart team discussion during the index hospitalization (up to 30 days from admission).)
- Seniority of participating specialist in heart team discussions(From index PCI procedure to discharge for the index hospitalization (up to 30 days))
- Multidisciplinary synchronous shared decision-making(From index PCI procedure to discharge for the index hospitalization (up to 30 days))
- Patient satisfaction with the decision-making process(Within 24 hours before discharge from the index hospitalization (up to 30 days from admission).)
- Recatheterization rate(During index hospitalization (typically within 30 days of admission))
- Specialist workload(During index hospitalization (typically within 30 days of admission))
- Real-time consultation response rate(During index hospitalization (typically within 30 days of admission))
- 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))
研究者
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