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| Name | Class |
|---|---|
| Fuwai Yunnan Cardiovascular Hospital | OTHER |
| Central China Fuwai Hospital of Zhengzhou University | OTHER |
| Shenzhen Sun Yat-sen Cardiovascular Hospital | OTHER |
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This is a multi-center, randomized controlled trial to compare the clinical outcomes between CT-derived fractional flow reserve (CT-FFR) guided strategy and angiography-derived quantitative flow ratio (QFR) guided strategy among patients with coronary artery disease (CAD). Participants who have at least one coronary stenosis of 70%-90% (vessel diameter ≥2.5 mm) detected by coronary CT angiography will be enrolled and are randomly assigned in a 1:1 ratio to CT-FFR guided group or QFR guided group. In CT-FFR group, the decisions of invasive angiography and revascularization will be guided by CT-FFR. In QFR group, the decision of invasive angiography will be made as usual care, and revascularization will be guided by QFR. The primary endpoint is the 1-year incidence of major adverse cardiac events (MACEs), including death, myocardial infarction, and unplanned revascularization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-FFR group | Experimental | The decisions of invasive angiography and revascularization will be guided by CT-FFR. |
|
| QFR group | Active Comparator | The decision of invasive angiography will be made as usual care, and revascularization will be guided by QFR. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-FFR guided strategy | Diagnostic Test | Patients in this group will undergo CT-derived fractional flow reserve (CT-FFR) analysis. If the CT-FFR value is ≤0.80, patients will subsequently undergo invasive coronary angiography (ICA) and receive coronary revascularization. If the CT-FFR values of all vessels are >0.80, patients will not undergo invasive angiography. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Major Adverse Cardiac Events (MACEs) within 12 Months Post-Procedure | MACEs is defined as a composite of all-cause death, myocardial infarction, and unplanned revascularization. | 12 Months Post-Procedural Follow-Up |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause death | Death from any cause during the follow-up period. | 12 Months After Randomization |
| Cardiac death | Death due to myocardial infarction, heart failure, or other cardiac causes. |
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Patient-level inclusion criteria:
Lesion-level inclusion criteria:
(1) Coronary CT angiography (CCTA) shows at least one coronary artery with 70%-90% diameter stenosis and vessel diameter ≥2.5 mm.
Patient-level exclusion criteria:
Lesion-level exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhe Zheng, MD, PhD | Contact | +86 88396051 | zhengzhe@fuwai.com |
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| Ruijin Hospital |
| OTHER |
| Nanjing First Hospital, Nanjing Medical University | OTHER |
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| The First Affiliated Hospital of Dalian Medical University | OTHER |
| Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER |
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|
| QFR guided strategy | Diagnostic Test | Patients in this group will undergo invasive coronary angiography (ICA) according to routine clinical indications. During the procedure, quantitative flow ratio (QFR) analysis will be performed. If the QFR value is ≤0.80, coronary revascularization will be performed. If the QFR value is >0.80, coronary revascularization will be forwent. |
|
| 12 Months After Randomization |
| Myocardial infarction (MI) | Defined according to the Fourth Universal Definition of Myocardial Infarction. | 12 Months After Randomization |
| Repeat revascularization | Any planned or unplanned revascularization of the target vessel or graft. | 12 Months After Randomization |
| Rehospitalization | Any hospital readmission for cardiac causes, recurrent angina, or other medical reasons. | 12 Months After Randomization |
| Rate of invasive coronary angiography avoidance | The proportion of patients who avoided invasive coronary angiography after CT-FFR-based evaluation without adverse clinical outcomes. | 12 Months After Randomization |
| Revascularization rate | The proportion of patients undergoing any coronary revascularization (PCI or CABG). | 12 Months After Randomization |
| Number of stents implanted or bypass grafts performed | to assess procedural extent and resource utilization | 12 Months After Randomization |
| Rate of optimal medical therapy | The proportion of patients treated conservatively without revascularization. | 12 Months After Randomization |
| PCI rate | The proportion of patients receiving percutaneous coronary intervention. | 12 Months After Randomization |
| CABG rate | The proportion of patients undergoing coronary artery bypass grafting. | 12 Months After Randomization |
| Total cost | Including outpatient and inpatient diagnostic and treatment expenses, index hospitalization cost. | 12 Months After Randomization |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| 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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