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| Name | Class |
|---|---|
| Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER |
| The First Affiliated Hospital of Dalian Medical University | OTHER |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real-time heart team group | Experimental | A online multidisciplinary heart team discussion and decision-making will be conducted during angiography |
|
| Usual care group | No Intervention | An usual care decision-making initiated by interventional cardiologists will be conducted |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real-Time Heart Team Decision-making | Other | A online multidisciplinary heart team discussion and decision-making will be conducted during coronary angiography. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical adverse events | Incidence and time to first clinical event, including: all-cause mortality, cardiac mortality, non-fatal myocardial infarction, stroke, target-vessel or graft revascularization, repeat revascularization, unplanned revascularization, rehospitalization for recurrent angina, cardiac rehospitalization, and all-cause rehospitalization. | From randomization through 1-year follow-up (events recorded during index hospitalization and at follow-up visits up to 12 months). |
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Inclusion Criteria (Fulfill 1,2,3 or 1,4):
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhe Zheng, MD, PhD | Contact | +86-88396051 | zhengzhe@fuwai.com |
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| Fuwai Yunnan Cardiovascular Hospital | OTHER |
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| Central China Fuwai Hospital of Zhengzhou University | OTHER |
| Ruijin Hospital | OTHER |
| Nanjing First Hospital, Nanjing Medical University | OTHER |
| Shenzhen Sun Yat-sen Cardiovascular Hospital | OTHER |
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| Guideline-concordant revascularization decision rate | Proportion of coronary revascularization decisions that are concordant with the Guidelines class I or IIa recommendations. | During index hospitalization (typically within 30 days of admission) |
| Percutaneous coronary intervention (PCI) utilization rate | Proportion of patients who undergo PCI as part of their coronary revascularization strategy. | During index hospitalization (typically within 30 days of admission) |
| Coronary artery bypass grafting (CABG) utilization rate | Proportion of patients who undergo CABG as part of their coronary revascularization strategy. | During index hospitalization (typically within 30 days of admission) |
| Medical therapy rate | Proportion of patients managed with medical therapy. | During index hospitalization (typically within 30 days of admission) |
| Waiting time from diagnostic angiography to treatment initiation | Time from completion of diagnostic coronary angiography to initiation of the definitive treatment strategy (PCI, CABG, or medical therapy). | During index hospitalization (typically within 30 days of admission) |
| Medical costs | Medical costs during the index hospitalization. | Index hospitalization until discharge (typically within 30 days of admission). |
| Hospital length of stay | Number of days from hospital admission to hospital discharge for the index hospitalization. | From hospital admission to discharge for the index hospitalization (up to 30 days). |
| Prolonged PCI hospitalization | Proportion of patients with prolonged length of stay after PCI, defined according to the Centers for Medicare and Medicaid Services (CMS) criteria. | From index PCI procedure to discharge for the index hospitalization (up to 30 days). |
| Time spent per heart team case | Duration of each heart team discussion. | At the time of the heart team discussion during the index hospitalization (up to 30 days from admission). |
| Specialist satisfaction with discussion adequacy | Satisfaction of participating specialists (interventional cardiologists and cardiac surgeons) with the adequacy of the discussion, assessed using a numeric rating scale (0-10, higher scores indicating greater satisfaction); reported as mean (±SD) score per group. | Immediately after each heart team discussion during the index hospitalization (up to 30 days from admission). |
| Seniority of participating specialist in heart team discussions | Proportion of specialists with different seniority, such as associated chief, chief etc.. | From index PCI procedure to discharge for the index hospitalization (up to 30 days) |
| Multidisciplinary synchronous shared decision-making | Proportion of cases in which interventional cardiology and cardiac surgery participate in a synchronous discussion with patient or relatives. | From index PCI procedure to discharge for the index hospitalization (up to 30 days) |
| Patient satisfaction with the decision-making process | Patient-reported satisfaction with the coronary revascularization decision-making process, assessed using a structured questionnaire with a 5-point Likert scale. | Within 24 hours before discharge from the index hospitalization (up to 30 days from admission). |
| Recatheterization rate | Repeat invasive coronary angiography after the index procedure. | During index hospitalization (typically within 30 days of admission) |
| Specialist workload | Workload of participating specialists based on NASA-TLX scale | During index hospitalization (typically within 30 days of admission) |
| Real-time consultation response rate | A real-time response from cardiac surgeon during the coronary angiography. | During index hospitalization (typically within 30 days of admission) |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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