Clinical Outcomes of CoroNary CTA-Derived FFR Versus ICA-Derived QFR-guided Strategy for Decision-Making in Patients With Stable Chest Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 4,648
- 试验地点
- 1
- 主要终点
- 1-year MACE
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (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
- •Age ≥18 years
- •with stable chest pain who underwent CCTA and have at least 1 lesion with a percent diameter stenosis (DS%) between 50% and 90% in a coronary artery with a ≥2.5 mm reference vessel diameter by visual assessment.These patients plan to undergo further non-invasive or invasive diagnosis and treatment.
- •Able to undergo invasive coronary angiography (ICA)
- •Capable of complying with the study procedures and fully understand the informed consent form approved by the ethics committee, and provide voluntary consent.
排除标准
- •General exclusion criteria:
- •Patients with acute coronary syndrome requiring urgent revascularization.
- •Patients with unstable angina, including those with first-onset chest pain within 48 hours, CCS III or higher first-onset angina, those whose angina has worsened to CCS III or IV within a short period of time, or those with rest angina lasting more than 20 minutes.
- •Patients with iodine contrast agent allergy.
- •Pregnant or lactating women.
- •Patients with severe congestive heart failure (NYHA III-IV or LVEF <30%) or acute pulmonary edema.
- •Patients with severe renal insufficiency (creatinine >150μmol/L or estimated - -glomerular filtration rate calculated by the Cockcroft-Gault formula <45ml/kg/1.73 m2).
- •Patients with other comorbidities and an expected survival time of less than 1 year.
- •Patients who, for any other reason, are considered by the investigators to be unsuitable for inclusion in the study or unable to complete the study and follow-up.
- •Coronary CTA and coronary angiography exclusion criteria:
- •Patients with a body mass index >35 when undergoing coronary CT testing, resulting in poor CT image quality due to motion artifacts, severe calcification, or inadequate iodine contrast agent filling.
- •Patients with a history of coronary artery bypass grafting (CABG).
- •Target lesions related to acute myocardial infarction.
- •Target lesions involving left main stem disease.
- •Target lesions involving myocardial bridging.
- •Target lesions involving in-stent restenosis.
- •Low-quality angiography due to poor visualization of vascular boundaries or poor iodine contrast agent filling.
- •Excessive overlap of the stenotic segment or severe tortuosity of the target vessel, making QFR calculation impossible.
结局指标
主要结局
1-year MACE
时间窗: 1-year
Major Adverse Coronary Event (MACE) rates, defined as: 1. All cause death 2. myocardial infarction (MI) 3. Repeat myocardial revascularization 4. non-lethal stroke
次要结局
- non-lethal stroke(1-month, 6-month, 1-year, 2-years, 3-years)
- The definite and probable stent thrombosis (defined by ARC-2 criteria)(1-month, 6-month, 1-year, 2-years, 3-years)
- All cause death(1-month, 6-month, 1-year, 2-years, 3-years)
- repeat myocardial(1-month, 6-month, 1-year, 2-years, 3-years)
- Health Economics Evaluation Endpoints(1-month, 6-month, 1-year, 2-years, 3-years)
- Cumulative radiation exposure(1-month, 6-month, 1-year, 2-years, 3-years)
- Proportion of non-obstructive CAD detected by ICA examination(1-month, 6-month, 1-year, 2-years, 3-years)
- MACE(1-month, 6-month, 2-years, 3-years)
- Non-fatal myocardial infarction (MI)(1-month, 6-month, 1-year, 2-years, 3-years)
- Quality of life (QOL)(1-month, 6-month, 1-year, 2-years, 3-years)