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NCT Number: NCT05380622

CHART Study of Coronary CT Angiography in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Zhongshan Hospital

Shanghai, China

Location status: Recruiting

Location contact

Junbo Ge, MD

PRINCIPAL_INVESTIGATOR

Neng Dai, MD

CONTACT

[email protected]

+8613701997266

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coronary CT angiography

Diagnostic Test

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.

Primary outcomes

  1. Frequency of occurrence of high-risk plaques

    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)

  2. 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 total plaque volume (adjusted by vessel volume) and plaque composition detected by follow up CCTA

  3. Change in WSS 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

  4. Change in APS 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

  5. Change in SSI 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

  6. Change in hemodynamic parameters delta fractional flow reserve 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

  7. Change in physiological pattern by PPG derived 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

  8. Change in dCT-FFR/ds detected by follow up CCTA

    Time frame: up to 5 years after index procedure

    Change in dCT-FFR/ds detected by follow up CCTA

  9. Change in CT-FFR

    Time frame: up to 5 years after index procedure

    Change in fractional flow reserve by CCTA

  10. Change in peri-coronary adipose tissue assessed by follow up CCTA

    Time frame: up to 5 years after index procedure

    Change in peri-coronary adipose tissue assessed by follow up CCTA

  11. CCTA-derived features associated with precursors of ACS or CCS

    Time frame: up to 5 years after index procedure

    CCTA-derived features associated with precursors of ACS or CCS

  12. Adverse cardiovascular event according to stenosis and plaque features, disease patterns, hemodynamic parameters, and fat metrics on CCTA along with physiologic assessment

    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.

  13. Adverse cardiovascular event according to different treatment strategies according to stenosis and plaque features, fat metrics on CCTA along with physiologic assessments.

    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.

Secondary outcomes

  1. Anginal status

    Time frame: up to 5 years after index procedure

    Change in Health Related Quality of Life (HRQL)

  2. Number of anti-anginal medication prescribed

    Time frame: up to 5 years after index procedure

    Number of anti-anginal medication prescribed

  3. Clinical predictors of events

    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.

  4. Prognostic value of CCTA defined anatomy and plaque characterization

    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.

  5. Prognostic value of WSS

    Time frame: up to 5 years after index procedure

    Prognostic value of WSS

  6. Prognostic value of APS

    Time frame: up to 5 years after index procedure

    Prognostic value of APS

  7. Prognostic value of SSI

    Time frame: up to 5 years after index procedure

    Prognostic value of SSI

  8. Prognostic value of delta CT-FFR

    Time frame: up to 5 years after index procedure

    Prognostic value of delta CT-FFR

  9. Prognostic value of pull pressure gradient

    Time frame: up to 5 years after index procedure

    Prognostic value of pull pressure gradient

  10. Prognostic value of dCT-FFR/ds

    Time frame: up to 5 years after index procedure

    Prognostic value of dCT-FFR/ds

  11. Prognostic value of per-coronary adipose tissue

    Time frame: up to 5 years after index procedure

    Prognostic value of per-coronary adipose tissue derived fat attenuation index and other radiomics features.

  12. Prognostic value of integrated CCTA based lesion anatomy, plaque characterization, hemodynamic parameters, physiological patterns and per-coronary adipose tissue for ACS

    Time frame: up to 5 years after index procedure

    Comparison of outcome discrimination ability.

  13. Prognostic value of integrated CCTA based lesion anatomy, plaque characterization, hemodynamic parameters, physiological patterns and per-coronary adipose tissue for cardiovascular events

    Time frame: up to 5 years after index procedure

    Comparison of outcome discrimination ability.

  14. Relationship among CT-derived plaque qualification and quantification, and CT-defined pericoronary and epicardial fat metrics with physiological assessments.

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Neng Dai, MD

CONTACT

[email protected]

+8613701997266

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Acronym: CHART-VISION

Important dates

Study start
2015
Primary completion
2025
Study completion
2030
First posted
May 19, 2022
Registry last updated
May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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