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CHART Study of Coronary CT Angiography in Coronary Artery Disease

CHART Study of Coronary CT Angiography to Predict Imaging and Cardiovascular Outcomes in Patients With Coronary Artery Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05380622
Acronym
CHART-VISION
Enrollment
5000
Registered
2022-05-19
Start date
2015-01-01
Completion date
2030-12-31
Last updated
2022-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Brief summary

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.

Detailed description

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.

Interventions

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.

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Frequency of occurrence of high-risk plaques30 daysFrequency (%) 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)
Change in total plaque volume (adjusted by vessel volume) and plaque composition detected by follow up CCTAup to 5 years after index procedureChange in total plaque volume (adjusted by vessel volume) and plaque composition detected by follow up CCTA
Change in WSS detected by follow up CCTAup to 5 years after index procedureChange in hemodynamic parameter of wall shear stress (WSS) detected by follow up CCTA
Change in APS detected by follow up CCTAup to 5 years after index procedureChange in hemodynamic parameter of axial plaque stress (APS) detected by follow up CCTA
Change in SSI detected by follow up CCTAup to 5 years after index procedureChange in stenosis susceptibility index (SSI) detected by follow up CCTA
Change in hemodynamic parameters delta fractional flow reserve detected by follow up CCTAup to 5 years after index procedureChange in hemodynamic parameters delta fractional flow reserve detected by follow up CCTA
Change in physiological pattern by PPG derived by follow up CCTAup to 5 years after index procedureChange in physiological pattern by pullback pressure gradient (PPG) derived by follow up CCTA
Change in dCT-FFR/ds detected by follow up CCTAup to 5 years after index procedureChange in dCT-FFR/ds detected by follow up CCTA
Change in CT-FFRup to 5 years after index procedureChange in fractional flow reserve by CCTA
Change in peri-coronary adipose tissue assessed by follow up CCTAup to 5 years after index procedureChange in peri-coronary adipose tissue assessed by follow up CCTA
CCTA-derived features associated with precursors of ACS or CCSup to 5 years after index procedureCCTA-derived features associated with precursors of ACS or CCS
Adverse cardiovascular event according to stenosis and plaque features, disease patterns, hemodynamic parameters, and fat metrics on CCTA along with physiologic assessmentup to 5 years after index procedureA composite of cardiac death, vessel-related myocardial infarction (MI), or vessel-related ischemia-driven revascularization.
Adverse cardiovascular event according to different treatment strategies according to stenosis and plaque features, fat metrics on CCTA along with physiologic assessments.up to 5 years after index procedureA composite of cardiac death, vessel-related myocardial infarction (MI), or vessel-related ischemia-driven revascularization.

Secondary

MeasureTime frameDescription
Anginal statusup to 5 years after index procedureChange in Health Related Quality of Life (HRQL)
Relationship among CT-derived plaque qualification and quantification, and CT-defined pericoronary and epicardial fat metrics with physiological assessments.up to 5 years after index procedureAssociation among CCTA parameters (including diameter stenosis, area stenosis, plaque components) and physiologic indices (CT-FFR, PPG, delta-FFR, dCT-FFR/ds).
Number of anti-anginal medication prescribedup to 5 years after index procedureNumber of anti-anginal medication prescribed
Clinical predictors of eventsup to 5 years after index procedureTo 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.
Prognostic value of CCTA defined anatomy and plaque characterizationup to 5 years after index procedurePrognostic value of CCTA defined anatomy including diameter stenosis, area stenosis and plaque characterization including plaque components, physiological on blood flow, diffuseness and inflammation.
Prognostic value of WSSup to 5 years after index procedurePrognostic value of WSS
Prognostic value of APSup to 5 years after index procedurePrognostic value of APS
Prognostic value of SSIup to 5 years after index procedurePrognostic value of SSI
Prognostic value of delta CT-FFRup to 5 years after index procedurePrognostic value of delta CT-FFR
Prognostic value of pull pressure gradientup to 5 years after index procedurePrognostic value of pull pressure gradient
Prognostic value of dCT-FFR/dsup to 5 years after index procedurePrognostic value of dCT-FFR/ds
Prognostic value of per-coronary adipose tissueup to 5 years after index procedurePrognostic value of per-coronary adipose tissue derived fat attenuation index and other radiomics features.
Prognostic value of integrated CCTA based lesion anatomy, plaque characterization, hemodynamic parameters, physiological patterns and per-coronary adipose tissue for ACSup to 5 years after index procedureComparison of outcome discrimination ability.
Prognostic value of integrated CCTA based lesion anatomy, plaque characterization, hemodynamic parameters, physiological patterns and per-coronary adipose tissue for cardiovascular eventsup to 5 years after index procedureComparison of outcome discrimination ability.

Countries

China

Contacts

Primary ContactNeng Dai, MD
niceday1987@hotmail.com+8613701997266

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026