Shanghai Zhongshan Hospital
Shanghai, China
Location status: Recruiting
NCT Number: NCT05380622
In a cohort of patients referred to coronary computed tomography angiography (CCTA), the investigators aim:
1. To describe the natural history of the coronary atherosclerotic plaque development and progression or regression, as well as the plaque characterization and phenotypes over time by CCTA among deferred coronary lesions 2. To explore the precursors of plaques leading to acute coronary syndrome (ACS) or chronic coronary syndrome (CCS) in deferred coronary lesions 3. To investigate prognostic implication of qualitative and quantitative plaque analysis of stenosis and plaque features, disease patterns, hemodynamic parameters, and fat metrics on CCTA along with physiologic assessment 4. To investigate the effects of different treatment strategies according to stenosis and plaque features, fat metrics on CCTA along with physiologic assessments.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Shanghai, China
Location status: Recruiting
Invasive physiologic indices such as fractional flow reserve (FFR) are used to define ischemia-causing stenosis and guide percutaneous coronary intervention (PCI) in the clinical practice. FFR-guided PCI has been proven to improve clinical outcomes, however, a substantial proportion of patients continue to experience clinical events. The ISCHEMIA trial showed that invasive therapy did not improve prognosis in patients with moderate to severe ischemia compared to optimal medical therapy. Besides, a recent study implied that even in vessels with FFR>0.80, those have lesions with high-risk plaque characteristics (HRPC) demonstrated worse clinical outcomes. This might be not unexpected since previous evidence from postmortem studies demonstrated that unstable atherosclerotic plaques are prone to rupture and trigger adverse cardiovascular events.
In recent years, advances in imaging analysis made it possible to conduct novel measurements such as pericoronary inflammation or epicardial fat metrics and lesion-specific or vessel-specific hemodynamic parameters derived from CCTA (such as fractional flow reserve by CCTA [CT-FFR]) as well as the coronary disease patterns defined by physiologic distribution (predominant focal versus diffuse disease defined by CCTA derived pullback pressure gradient index) and local severity (presence versus absence of major gradient defined by CCTA-derived FFR gradient per unit length [dCT-FFR/ds]) of coronary atherosclerosis.
However, the relationship of these parameters and the combination of these indices on clinical outcomes has not been fully understood. Furthermore, though it has been known that high-risk plaques are related with worse outcomes even no significant blood flow impairment induced, best treatment strategy for these lesions remains unclear.
In this regard, the aims of this study are multiple, all the treatment strategies are at the discretion of the physicians in charge. For patients without further invasive angiography performed after CCTA or deferred for revascularization after invasive angiography with/without physiology or imaging assessments, the investigators will investigate coronary atherosclerotic plaque development and progression or regression, as well as the plaque characterization and phenotypes over time by CCTA, and to explore the precursors of plaques leading to acute coronary syndrome (ACS) or chronic coronary syndrome (CCS); for those with received revascularization, the investigators will investigate the prognostic value of CCTA based comprehensive analysis of coronary in combination with physiologic assessment. In all patients, the effects of different treatment strategies according to stenosis and plaque features, fat metrics as well as physiologic assessments will be investigated.
CHART is a study group called Chinese Non-invasive Cardiovascular Imaging and Physiology Study Group, the current study will be conducted by CHART and by invitation in multiple Chinese centers.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Coronary CT angiography (CCTA) will be performed according to standard protocol and measurement of fractional flow reserve (FFR) or other physiological indices will be at the at the discretion of the physicians in charge.
Stenosis and plaque features, disease patterns, hemodynamic parameters, and fat metrics on CCTA will be analyzed blindly in the core lab.
Time frame: 30 days
Frequency (%) of occurrence of high-risk plaque morphologic features (Housfield Unit[HU]<30, Remodelling Index > 1.1, napkin-ring sign, spotty calcium, minimal lumen area[MLA]<4mm2 & plaque burden[PB]≥70%), physiologic diffuse disease, inflammation by high fat attenuation index (FAI)
Time frame: up to 5 years after index procedure
Change in total plaque volume (adjusted by vessel volume) and plaque composition detected by follow up CCTA
Time frame: up to 5 years after index procedure
Change in hemodynamic parameter of wall shear stress (WSS) detected by follow up CCTA
Time frame: up to 5 years after index procedure
Change in hemodynamic parameter of axial plaque stress (APS) detected by follow up CCTA
Time frame: up to 5 years after index procedure
Change in stenosis susceptibility index (SSI) detected by follow up CCTA
Time frame: up to 5 years after index procedure
Change in hemodynamic parameters delta fractional flow reserve detected by follow up CCTA
Time frame: up to 5 years after index procedure
Change in physiological pattern by pullback pressure gradient (PPG) derived by follow up CCTA
Time frame: up to 5 years after index procedure
Change in dCT-FFR/ds detected by follow up CCTA
Time frame: up to 5 years after index procedure
Change in fractional flow reserve by CCTA
Time frame: up to 5 years after index procedure
Change in peri-coronary adipose tissue assessed by follow up CCTA
Time frame: up to 5 years after index procedure
CCTA-derived features associated with precursors of ACS or CCS
Time frame: up to 5 years after index procedure
A composite of cardiac death, vessel-related myocardial infarction (MI), or vessel-related ischemia-driven revascularization.
Time frame: up to 5 years after index procedure
A composite of cardiac death, vessel-related myocardial infarction (MI), or vessel-related ischemia-driven revascularization.
Time frame: up to 5 years after index procedure
Change in Health Related Quality of Life (HRQL)
Time frame: up to 5 years after index procedure
Number of anti-anginal medication prescribed
Time frame: up to 5 years after index procedure
To find out the models with baseline characteristics including age, sex, cardiovascular risk factors and so on with the highest area under curve to predict a composite of cardiac death, vessel-related myocardial infarction (MI), or vessel-related ischemia-driven revascularization.
Time frame: up to 5 years after index procedure
Prognostic value of CCTA defined anatomy including diameter stenosis, area stenosis and plaque characterization including plaque components, physiological on blood flow, diffuseness and inflammation.
Time frame: up to 5 years after index procedure
Prognostic value of WSS
Time frame: up to 5 years after index procedure
Prognostic value of APS
Time frame: up to 5 years after index procedure
Prognostic value of SSI
Time frame: up to 5 years after index procedure
Prognostic value of delta CT-FFR
Time frame: up to 5 years after index procedure
Prognostic value of pull pressure gradient
Time frame: up to 5 years after index procedure
Prognostic value of dCT-FFR/ds
Time frame: up to 5 years after index procedure
Prognostic value of per-coronary adipose tissue derived fat attenuation index and other radiomics features.
Time frame: up to 5 years after index procedure
Comparison of outcome discrimination ability.
Time frame: up to 5 years after index procedure
Comparison of outcome discrimination ability.
Time frame: up to 5 years after index procedure
Association among CCTA parameters (including diameter stenosis, area stenosis, plaque components) and physiologic indices (CT-FFR, PPG, delta-FFR, dCT-FFR/ds).
Contact information is provided by the study sponsor or research team.
Shanghai Zhongshan Hospital
Other
CHART Study of Coronary CT Angiography to Predict Imaging and Cardiovascular Outcomes in Patients With Coronary Artery Disease
Acronym: CHART-VISION
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