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.
Study Type
OBSERVATIONAL
Enrollment
3,000
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGComposite of All-cause Death, Myocardial Infarction (MI), or Ischemia-driven Revascularization
The primary endpoint is defined as the composite occurrence of all-cause death, myocardial infarction (MI), or ischemia-driven revascularization.
Time frame: 12 months after enrollment
Primary Endpoint Excluding Periprocedural MI
The primary composite endpoint of all-cause death, myocardial infarction, or ischemia-driven revascularization, excluding periprocedural myocardial infarction.
Time frame: 12 months after enrollment
Composite of All-cause Death, Myocardial Infarction (MI), or Ischemia-driven Revascularization
The primary endpoint is defined as the composite occurrence of all-cause death, myocardial infarction (MI), or ischemia-driven revascularization.
Time frame: 24 and 60 months after enrollment
Individual Components of the Primary Endpoint
The occurrence of the individual components of the primary composite endpoint, analyzed separately. These include all-cause death, myocardial infarction, and ischemia-driven revascularization.
Time frame: 12 months after enrollment
Target Vessel Failure (TVF)
A composite endpoint including cardiac death, target vessel myocardial infarction (MI), or target vessel revascularization.
Time frame: 12, 24, and 60 months after enrollment
Health Economics Analysis
Cost-effectiveness analysis of the diagnostic and treatment strategies.
Time frame: 12, 24, and 60 months after enrollment
All-cause Death and Cardiac Death
The rate of death from any cause and death from cardiac causes specifically.
Time frame: 12, 24, and 60 months after enrollment
Non-fatal Myocardial Infarction Including Periprocedural MI
The occurrence of non-fatal myocardial infarction (including both target vessel-related and all-cause events), inclusive of periprocedural myocardial infarction.
Time frame: 12, 24, and 60 months after enrollment
Non-fatal Myocardial Infarction Excluding Periprocedural MI
The occurrence of non-fatal myocardial infarction (including both target vessel-related and all-cause events), excluding periprocedural myocardial infarction.
Time frame: 12, 24, and 60 months after enrollment
Revascularization
The occurrence of any target vessel/lesion revascularization, any non-target vessel/lesion revascularization, and any revascularization (whether ischemia-driven or all-cause)
Time frame: 12, 24, and 60 months after enrollment
Target Vessel or Target Lesion Revascularization
The occurrence of any revascularization procedure involving the target vessel (TVR) or target lesion (TLR).
Time frame: 12, 24, and 60 months after enrollment
Non-Target Vessel or Non-Target Lesion Revascularization
The occurrence of any revascularization procedure involving a non-target vessel (non-TVR) or non-target lesion (non-TLR).
Time frame: 12, 24, and 60 months after enrollment
Stroke
The occurrence of non-fatal stroke, including both ischemic and hemorrhagic types.
Time frame: 12, 24, and 60 months after enrollment
CT Plaque Characteristics and Clinical Associations
The association between CT plaque characteristics, clinical features, and outcomes.
Time frame: Baseline, 12, 24, and 60 months after enrollment
Correlation of Non-invasive and Invasive Indices
The correlation of CCTA and CT-derived functional indices (such as CT-IMR) with invasive anatomical and functional indices.
Time frame: Baseline
Subgroup Analysis of Imaging Features and Clinical Outcomes
The association of specific patient factors-gender differences, diabetes status, and age-with imaging features and clinical outcomes.
Time frame: 12, 24, and 60 months after enrollment
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