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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abnormal CT-FFR Cohort | Patients diagnosed with chronic coronary syndrome who underwent coronary computed tomography angiography (CCTA) and computed tomography-derived fractional flow reserve (CT-FFR) evaluation, with a lowest per-patient CT-FFR value of ≤ 0.80. | ||
| Normal CT-FFR Cohort | Patients diagnosed with chronic coronary syndrome who underwent coronary computed tomography angiography (CCTA) and computed tomography-derived fractional flow reserve (CT-FFR) evaluation, with a lowest per-patient CT-FFR value of > 0.80. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint Excluding Periprocedural MI | The primary composite endpoint of all-cause death, myocardial infarction, or ischemia-driven revascularization, excluding periprocedural myocardial infarction. | 12 months after enrollment |
| Composite of All-cause Death, Myocardial Infarction (MI), or Ischemia-driven Revascularization |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of patients with chronic coronary syndrome (CCS) who undergo coronary computed tomography angiography (CCTA) and CT-derived fractional flow reserve (CT-FFR) evaluation as part of their routine clinical care. Participants are consecutively recruited from multiple tertiary medical centers across China to ensure a representative real-world cohort. This population reflects the broad clinical spectrum of CCS patients encountered in actual practice, encompassing a wide range of coronary disease severity as assessed by non-invasive functional imaging.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Jiang, MD | Contact | +(86) 13588706891 | jiang-jun@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jun Jiang, MD | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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The primary endpoint is defined as the composite occurrence of all-cause death, myocardial infarction (MI), or ischemia-driven revascularization. |
| 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. | 12 months after enrollment |
| Target Vessel Failure (TVF) | A composite endpoint including cardiac death, target vessel myocardial infarction (MI), or target vessel revascularization. | 12, 24, and 60 months after enrollment |
| Health Economics Analysis | Cost-effectiveness analysis of the diagnostic and treatment strategies. | 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. | 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. | 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. | 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) | 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). | 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). | 12, 24, and 60 months after enrollment |
| Stroke | The occurrence of non-fatal stroke, including both ischemic and hemorrhagic types. | 12, 24, and 60 months after enrollment |
| CT Plaque Characteristics and Clinical Associations | The association between CT plaque characteristics, clinical features, and outcomes. | 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. | 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. | 12, 24, and 60 months after enrollment |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |