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This study is a multicenter, prospective, blinded (blinding of clinical evaluators), randomized controlled, event-driven non-inferiority clinical trial. Eligible subjects who meet the inclusion criteria will be registered in the central randomization system and randomized in a 1:1 ratio to either the experimental group (CT-FFR guided group) or the control group (QFR guided group).
This study is a multicenter, prospective, blinded, randomized controlled trial with event-driven non-inferiority design (blinding of clinical evaluators). A total of 4,648 participants will be recruited and randomly assigned to the CT-FFR guided group or the QFR guided group in a 1:1 ratio. Patients in the experimental group (CT-FFR guided group) will undergo three-dimensional reconstruction of coronary arteries and CT-FFR calculation using coronary CT angiography (CCTA) images and the RuiXin-FFR software. The CT-FFR results will be interpreted and analyzed by the researchers. If the CT-FFR value is >0.8, patients will receive medical therapy only, while if the CT-FFR value is ≤0.8, patients will undergo further coronary angiography to determine the appropriate treatment strategy (PCI, CABG, or medical therapy), based on the anatomical features of the lesion and CT-FFR results. Patients in the control group (QFR guided group) will undergo invasive coronary angiography (ICA) and QFR calculation based on ICA images. If the QFR value is ≤0.8 and the lesion is suitable for intervention, patients will receive PCI, while if the QFR value is >0.8, medical therapy will be recommended. Both groups will be followed up for clinical outcomes, health economics indicators, and quality of life at 1 month, 6 months, 1 year, 2 years, and 3 years. The occurrence of major adverse cardiovascular events (MACE) will be compared between the two groups. The study will also assess the effectiveness, safety, and economic value of CT-FFR in guiding diagnosis and treatment decisions for patients with stable angina, using QFR guided PCI as a control, with a non-inferiority comparison.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-FFR guided group | Experimental | Patients randomized to the experimental group (CT-FFR guided group) will undergo coronary artery three-dimensional reconstruction and CT-FFR calculation using the coronary CT angiography (CCTA) images and RuiXin-FFR software. The researchers will interpret and analyze the clinical outcomes based on CT-FFR results. If CT-FFR is >0.8, the patient will be treated with medical therapy alone. If CT-FFR is ≤0.8, further examination with coronary angiography will be performed. During the angiography examination, the operator will determine the treatment strategy (PCI, CABG, or medical therapy alone) based on the anatomical features of the lesion and the CT-FFR results. |
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| QFR guided group | Active Comparator | Patients randomized to the control group (QFR-guided group) will undergo invasive coronary angiography (ICA) in the catheterization lab, and QFR will be calculated using the ICA images. The researchers will interpret and analyze the clinical outcomes based on QFR results. If QFR is ≤0.8 and the lesion is suitable for intervention, the patient will undergo percutaneous coronary intervention (PCI) treatment. If QFR is >0.8, the patient will be recommended for medical treatment alone. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-FFR | Device | CT -FFR(coronary computed tomography angiography drived fractional flow reserve derived) uses routine coronary computed tomography angiography (CTA) images and applies a specific algorithm to extract both anatomical and physiological information of the coronary arteries. By combining these two pieces of information, a fluid dynamics model of the coronary arteries can be established, allowing the calculation of FFR at any location of the coronary arteries. |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year MACE | Major Adverse Coronary Event (MACE) rates, defined as:
| 1-year |
| Measure | Description | Time Frame |
|---|---|---|
| MACE | Major Adverse Coronary Event (MACE) rates, defined as:
| 1-month, 6-month, 2-years, 3-years |
| All cause death |
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Inclusion Criteria:
Exclusion Criteria:
General exclusion criteria:
Coronary CTA and coronary angiography exclusion criteria:
Regen
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| chenguang Li, doctor | Contact | 13816767665 | li.chenguang@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| junbo Ge, doctor | Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Shanghai | Shagnhai | 200032 | China |
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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| QFR | Device | Quantitative flow ratio (QFR) is a new method for evaluating the functional significance of coronary artery stenosis based on angiography. It can be used for real-time detection of hemodynamic abnormalities in the coronary arteries in the catheterization lab. Unlike traditional methods that require the use of pressure wires and vasodilators such as adenosine, the QFR examination process only requires routine coronary angiography. By reconstructing the three-dimensional structure of the blood vessels and analyzing the hemodynamics, the QFR can evaluate the fractional flow reserve (FFR) without the need for pressure wires and vasodilators. |
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All cause death defined as:
Cardiovascular death, non-cardiovascular death, death of unknown cause
| 1-month, 6-month, 1-year, 2-years, 3-years |
| Non-fatal myocardial infarction (MI) | myocardial infarction (MI) defined as: Spontaneous myocardial infarction , perioperative myocardial infarction | 1-month, 6-month, 1-year, 2-years, 3-years |
| repeat myocardial | Repeat myocardial defined as:Planned revascularization,Unplanned revascularization | 1-month, 6-month, 1-year, 2-years, 3-years |
| non-lethal stroke | The American Heart Association/American Stroke Association (AHA/ASA) defines stroke as including the following types:CNS infarction,Ischemic stroke,Silent CNS infarction,Intracerebral hemorrhage,Subarachnoid hemorrhage,Cerebral venous thrombosis | 1-month, 6-month, 1-year, 2-years, 3-years |
| The definite and probable stent thrombosis (defined by ARC-2 criteria) | The definite and probable stent thrombosis (defined by ARC-2 criteria) including acute, subacute, late, and very late stent thrombosis within a specific time frame. | 1-month, 6-month, 1-year, 2-years, 3-years |
| Proportion of non-obstructive CAD detected by ICA examination | Proportion of non-obstructive CAD detected by ICA examination | 1-month, 6-month, 1-year, 2-years, 3-years |
| Health Economics Evaluation Endpoints | Cost-effectiveness analysis, cost-utility analysis. The information collected by the cost indicators is as follows:
| 1-month, 6-month, 1-year, 2-years, 3-years |
| Quality of life (QOL) | Quality of life (QOL) will be assessed using the EQ-5D-VAS questionnaire. Angina status will be assessed using the Seattle Angina Questionnaire. | 1-month, 6-month, 1-year, 2-years, 3-years |
| Cumulative radiation exposure | Cumulative radiation exposure within1-month, 6-month, 1-year, 2-years and 3-years of study entry included all cardiovascular tests and invasive procedures, including CTA, myocardial perfusion imaging, and ICA. | 1-month, 6-month, 1-year, 2-years, 3-years |
| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |