Coronary Artery Disease
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Second Affiliated Hospital, Zhejiang University, School of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of All-cause Death, Myocardial Infarction (MI), or Ischemia-driven Revascularization | 12 months after enrollment | The primary endpoint is defined as the composite occurrence of all-cause death, myocardial infarction (MI), or ischemia-driven revascularization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint Excluding Periprocedural MI | 12 months after enrollment | The primary composite endpoint of all-cause death, myocardial infarction, or ischemia-driven revascularization, excluding periprocedural myocardial infarction. |
| Composite of All-cause Death, Myocardial Infarction (MI), or Ischemia-driven Revascularization | 24 and 60 months after enrollment | The primary endpoint is defined as the composite occurrence of all-cause death, myocardial infarction (MI), or ischemia-driven revascularization. |
| Individual Components of the Primary Endpoint | 12 months after enrollment | The occurrence of the individual components of the primary composite endpoint, analyzed separately. These include all-cause death, myocardial infarction, and ischemia-driven revascularization. |
| Target Vessel Failure (TVF) | 12, 24, and 60 months after enrollment | A composite endpoint including cardiac death, target vessel myocardial infarction (MI), or target vessel revascularization. |
| Health Economics Analysis | 12, 24, and 60 months after enrollment | Cost-effectiveness analysis of the diagnostic and treatment strategies. |
| All-cause Death and Cardiac Death | 12, 24, and 60 months after enrollment | The rate of death from any cause and death from cardiac causes specifically. |
| Non-fatal Myocardial Infarction Including Periprocedural MI | 12, 24, and 60 months after enrollment | The occurrence of non-fatal myocardial infarction (including both target vessel-related and all-cause events), inclusive of periprocedural myocardial infarction. |
| Non-fatal Myocardial Infarction Excluding Periprocedural MI | 12, 24, and 60 months after enrollment | The occurrence of non-fatal myocardial infarction (including both target vessel-related and all-cause events), excluding periprocedural myocardial infarction. |
| Revascularization | 12, 24, and 60 months after enrollment | The occurrence of any target vessel/lesion revascularization, any non-target vessel/lesion revascularization, and any revascularization (whether ischemia-driven or all-cause) |
| Target Vessel or Target Lesion Revascularization | 12, 24, and 60 months after enrollment | The occurrence of any revascularization procedure involving the target vessel (TVR) or target lesion (TLR). |
| Non-Target Vessel or Non-Target Lesion Revascularization | 12, 24, and 60 months after enrollment | The occurrence of any revascularization procedure involving a non-target vessel (non-TVR) or non-target lesion (non-TLR). |
| Stroke | 12, 24, and 60 months after enrollment | The occurrence of non-fatal stroke, including both ischemic and hemorrhagic types. |
| CT Plaque Characteristics and Clinical Associations | Baseline, 12, 24, and 60 months after enrollment | The association between CT plaque characteristics, clinical features, and outcomes. |
| Correlation of Non-invasive and Invasive Indices | Baseline | The correlation of CCTA and CT-derived functional indices (such as CT-IMR) with invasive anatomical and functional indices. |
| Subgroup Analysis of Imaging Features and Clinical Outcomes | 12, 24, and 60 months after enrollment | The association of specific patient factors-gender differences, diabetes status, and age-with imaging features and clinical outcomes. |
Countries
China
Contacts
CONTACTJun Jiang, MD
PRINCIPAL_INVESTIGATORJun Jiang, MD
Second Affiliated Hospital, Zhejiang University, School of Medicine
Outcome results
None listed