Assessment of CT-FFR in Patients With CCS: A Prospective Multicenter Cohort Study

Официальное название

Assessment of Coronary Computed Tomography-Derived Fractional Flow Reserve in Patients With Chronic Coronary Syndrome: A Prospective Multicenter Cohort Study

Обзор

The ACCURATE-PRO study is an investigator-initiated, prospective, multicenter, observational, real-world cohort study. The core objective in managing chronic coronary syndrome (CCS) is to identify clinically significant myocardial ischemia to guide treatment decisions and improve long-term prognosis. While coronary computed tomography angiography (CCTA) is a crucial non-invasive anatomical imaging tool, it has limitations in determining the functional significance of coronary stenosis. Computed tomography-derived fractional flow reserve (CT-FFR) provides this functional assessment non-invasively based on CCTA images. However, there is a lack of systematic, prospective, multicenter evidence regarding its clinical value in risk stratification, treatment decision support, and prognostic evaluation for a continuous, real-world spectrum of CCS patients in China. This study aims to evaluate the relationship between abnormal CT-FFR results and the risk of 1-year major adverse clinical events in CCS patients undergoing CCTA and CT-FFR. The study hypothesizes that abnormal CT-FFR is associated with a higher risk of 12-month major adverse clinical events, and that CT-FFR results are significantly correlated with subsequent treatment strategies, providing important value in risk stratification and mid-to-long-term prognosis. The trial plans to consecutively enroll approximately 3,000 patients across multiple clinical centers in China. Eligible participants must be 18 years or older, have a clinical diagnosis of CCS, and have successfully obtained CT-FFR results following a CCTA examination. Patients will be excluded if they have acute coronary syndrome (such as STEMI, NSTEMI, or acute unstable angina), unanalyzable CT-FFR results/image quality, or non-cardiac conditions limiting their life expectancy to less than one year. Since this is an observational study, it will not alter routine clinical care pathways or assign interventions. The primary exposure factor analyzed will be the lowest CT-FFR result per patient, comparing an abnormal CT-FFR group (≤ 0.80) to a normal CT-FFR group (\> 0.80). Participants will be followed up via telephone, outpatient visits, or hospitalization at 6, 12, 24, and 60 months after enrollment. The primary endpoint is a composite of all-cause death, myocardial infarction (MI), or ischemia-driven revascularization within 1 year after enrollment. Key secondary endpoints include the occurrence of the primary endpoint at 24 and 60 months, target vessel failure (a composite of cardiac death, target vessel MI, or target vessel revascularization), stroke, health economics analysis, and the association between CT plaque characteristics and clinical outcomes.

Первичные конечные точки

• Composite of All-cause Death, Myocardial Infarction (MI), or Ischemia-driven Revascularization [Срок оценки: 12 months after enrollment]

Вторичные конечные точки (12)

• Primary Endpoint Excluding Periprocedural MI [Срок оценки: 12 months after enrollment]
• Composite of All-cause Death, Myocardial Infarction (MI), or Ischemia-driven Revascularization [Срок оценки: 24 and 60 months after enrollment]
• Individual Components of the Primary Endpoint [Срок оценки: 12 months after enrollment]
• Target Vessel Failure (TVF) [Срок оценки: 12, 24, and 60 months after enrollment]
• Health Economics Analysis [Срок оценки: 12, 24, and 60 months after enrollment]
• All-cause Death and Cardiac Death [Срок оценки: 12, 24, and 60 months after enrollment]
• Non-fatal Myocardial Infarction Including Periprocedural MI [Срок оценки: 12, 24, and 60 months after enrollment]
• Non-fatal Myocardial Infarction Excluding Periprocedural MI [Срок оценки: 12, 24, and 60 months after enrollment]
• Revascularization [Срок оценки: 12, 24, and 60 months after enrollment]
• Target Vessel or Target Lesion Revascularization [Срок оценки: 12, 24, and 60 months after enrollment]
• Non-Target Vessel or Non-Target Lesion Revascularization [Срок оценки: 12, 24, and 60 months after enrollment]
• Stroke [Срок оценки: 12, 24, and 60 months after enrollment]

Критерии участия

Критерии включения

• Age ≥ 18 years.
• Clinical diagnosis of chronic coronary syndrome (CCS).
• Completed coronary computed tomography angiography (CCTA) examination and successfully obtained CT-derived fractional flow reserve (CT-FFR) results.
• The subject or their legal representative voluntarily participates in this study and has signed the written informed consent form.

Критерии исключения

• Acute coronary syndrome (ACS), including ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI), or acute episodes of unstable angina.
• Unable to obtain valid CT-FFR results, or the image quality is insufficient to support analysis.
• Pregnant patients or those who intend to become pregnant during the study period.
• Non-cardiac comorbidities indicating a life expectancy of less than one year.
• Failure to sign the informed consent form.
• Inability to complete the follow-up or explicit refusal to participate in the follow-up.
• Patients with cognitive impairment or psychiatric disorders confirmed by clinical diagnosis or investigator assessment.
• Patients who are illiterate or semi-literate, or who, due to any visual impairment or reading/writing disability, are unable to independently read the subject information sheet without assistance and are unable to personally provide written informed consent.
• Any other conditions deemed unsuitable for participation in this study by the investigators

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Second Affiliated Hospital, School of Medicine, Zhejiang University — Ханчжоу

Идентификаторы

NCT: NCT07659119 · 2026-0520

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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