Coronary Artery Disease Clinical Trial
— CHART-VISIONOfficial title:
CHART Study of Coronary CT Angiography to Predict Imaging and Cardiovascular Outcomes in Patients With Coronary Artery Disease
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.
Status | Recruiting |
Enrollment | 5000 |
Est. completion date | December 31, 2030 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients with an indication for CCTA. - Qualified patients who have signed a written informed consent form. Exclusion Criteria: - Left ventricular ejection fraction < 35% - Acute ST-elevation myocardial infarction within 72 hours or previous coronary artery bypass graft surgery - Abnormal epicardial coronary flow (TIMI flow < 3) - Planned coronary artery bypass graft surgery after diagnostic angiography - Poor quality of CCTA or other reasons by core lab that are unsuitable for plaque, physiological or fat analysis - Patients with a stent in the target vessel |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Zhongshan Hospital | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Zhongshan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of occurrence of high-risk plaques | 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) | 30 days | |
Primary | Change in total plaque volume (adjusted by vessel volume) and plaque composition detected by follow up CCTA | Change in total plaque volume (adjusted by vessel volume) and plaque composition detected by follow up CCTA | up to 5 years after index procedure | |
Primary | Change in WSS detected by follow up CCTA | Change in hemodynamic parameter of wall shear stress (WSS) detected by follow up CCTA | up to 5 years after index procedure | |
Primary | Change in APS detected by follow up CCTA | Change in hemodynamic parameter of axial plaque stress (APS) detected by follow up CCTA | up to 5 years after index procedure | |
Primary | Change in SSI detected by follow up CCTA | Change in stenosis susceptibility index (SSI) detected by follow up CCTA | up to 5 years after index procedure | |
Primary | Change in hemodynamic parameters delta fractional flow reserve detected by follow up CCTA | Change in hemodynamic parameters delta fractional flow reserve detected by follow up CCTA | up to 5 years after index procedure | |
Primary | Change in physiological pattern by PPG derived by follow up CCTA | Change in physiological pattern by pullback pressure gradient (PPG) derived by follow up CCTA | up to 5 years after index procedure | |
Primary | Change in dCT-FFR/ds detected by follow up CCTA | Change in dCT-FFR/ds detected by follow up CCTA | up to 5 years after index procedure | |
Primary | Change in CT-FFR | Change in fractional flow reserve by CCTA | up to 5 years after index procedure | |
Primary | Change in peri-coronary adipose tissue assessed by follow up CCTA | Change in peri-coronary adipose tissue assessed by follow up CCTA | up to 5 years after index procedure | |
Primary | CCTA-derived features associated with precursors of ACS or CCS | CCTA-derived features associated with precursors of ACS or CCS | up to 5 years after index procedure | |
Primary | Adverse cardiovascular event according to stenosis and plaque features, disease patterns, hemodynamic parameters, and fat metrics on CCTA along with physiologic assessment | A composite of cardiac death, vessel-related myocardial infarction (MI), or vessel-related ischemia-driven revascularization. | up to 5 years after index procedure | |
Primary | Adverse cardiovascular event according to different treatment strategies according to stenosis and plaque features, fat metrics on CCTA along with physiologic assessments. | A composite of cardiac death, vessel-related myocardial infarction (MI), or vessel-related ischemia-driven revascularization. | up to 5 years after index procedure | |
Secondary | Anginal status | Change in Health Related Quality of Life (HRQL) | up to 5 years after index procedure | |
Secondary | Number of anti-anginal medication prescribed | Number of anti-anginal medication prescribed | up to 5 years after index procedure | |
Secondary | Clinical predictors of events | 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. | up to 5 years after index procedure | |
Secondary | Prognostic value of CCTA defined anatomy and plaque characterization | Prognostic value of CCTA defined anatomy including diameter stenosis, area stenosis and plaque characterization including plaque components, physiological on blood flow, diffuseness and inflammation. | up to 5 years after index procedure | |
Secondary | Prognostic value of WSS | Prognostic value of WSS | up to 5 years after index procedure | |
Secondary | Prognostic value of APS | Prognostic value of APS | up to 5 years after index procedure | |
Secondary | Prognostic value of SSI | Prognostic value of SSI | up to 5 years after index procedure | |
Secondary | Prognostic value of delta CT-FFR | Prognostic value of delta CT-FFR | up to 5 years after index procedure | |
Secondary | Prognostic value of pull pressure gradient | Prognostic value of pull pressure gradient | up to 5 years after index procedure | |
Secondary | Prognostic value of dCT-FFR/ds | Prognostic value of dCT-FFR/ds | up to 5 years after index procedure | |
Secondary | Prognostic value of per-coronary adipose tissue | Prognostic value of per-coronary adipose tissue derived fat attenuation index and other radiomics features. | up to 5 years after index procedure | |
Secondary | Prognostic value of integrated CCTA based lesion anatomy, plaque characterization, hemodynamic parameters, physiological patterns and per-coronary adipose tissue for ACS | Comparison of outcome discrimination ability. | up to 5 years after index procedure | |
Secondary | Prognostic value of integrated CCTA based lesion anatomy, plaque characterization, hemodynamic parameters, physiological patterns and per-coronary adipose tissue for cardiovascular events | Comparison of outcome discrimination ability. | up to 5 years after index procedure | |
Secondary | Relationship among CT-derived plaque qualification and quantification, and CT-defined pericoronary and epicardial fat metrics with physiological assessments. | Association among CCTA parameters (including diameter stenosis, area stenosis, plaque components) and physiologic indices (CT-FFR, PPG, delta-FFR, dCT-FFR/ds). | up to 5 years after index procedure |
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