Clinical Outcomes of CT-FFR Versus QFR-guided Strategy for Decision-Making in Patients With Stable Chest Pain

Официальное название

Clinical Outcomes of CoroNary CTA-Derived FFR Versus ICA-Derived QFR-guided Strategy for Decision-Making in Patients With Stable Chest Pain

Обзор

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).

Подробное описание

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.

Вмешательства

• Устройство CT-FFR
  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.
• Устройство QFR
  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 ves

Первичные конечные точки

• 1-year MACE [Срок оценки: 1-year]

Вторичные конечные точки (10)

• MACE [Срок оценки: 1-month, 6-month, 2-years, 3-years]
• All cause death [Срок оценки: 1-month, 6-month, 1-year, 2-years, 3-years]
• Non-fatal myocardial infarction (MI) [Срок оценки: 1-month, 6-month, 1-year, 2-years, 3-years]
• repeat myocardial [Срок оценки: 1-month, 6-month, 1-year, 2-years, 3-years]
• non-lethal stroke [Срок оценки: 1-month, 6-month, 1-year, 2-years, 3-years]
• The definite and probable stent thrombosis (defined by ARC-2 criteria) [Срок оценки: 1-month, 6-month, 1-year, 2-years, 3-years]
• Proportion of non-obstructive CAD detected by ICA examination [Срок оценки: 1-month, 6-month, 1-year, 2-years, 3-years]
• Health Economics Evaluation Endpoints [Срок оценки: 1-month, 6-month, 1-year, 2-years, 3-years]
• Quality of life (QOL) [Срок оценки: 1-month, 6-month, 1-year, 2-years, 3-years]
• Cumulative radiation exposure [Срок оценки: 1-month, 6-month, 1-year, 2-years, 3-years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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.

Regen

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Китай · 1 центр

• Zhongshan Hospital, Fudan University — Шанхай

Идентификаторы

NCT: NCT05857904 · RX-RD-FFR-FA-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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