跳至主要内容
临床试验/NCT05380622
NCT05380622招募中不适用

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

Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
5,000
试验地点
1
主要终点
Change in WSS detected by follow up CCTA

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with an indication for CCTA.
  • Qualified patients who have signed a written informed consent form.

排除标准

  • 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

结局指标

主要结局

Change in WSS detected by follow up CCTA

时间窗: up to 5 years after index procedure

Change in hemodynamic parameter of wall shear stress (WSS) detected by follow up CCTA

Change in total plaque volume (adjusted by vessel volume) and plaque composition detected by follow up CCTA

时间窗: up to 5 years after index procedure

Change in total plaque volume (adjusted by vessel volume) and plaque composition detected by follow up CCTA

Frequency of occurrence of high-risk plaques

时间窗: 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)

Change in hemodynamic parameters delta fractional flow reserve detected by follow up CCTA

时间窗: up to 5 years after index procedure

Change in hemodynamic parameters delta fractional flow reserve detected by follow up CCTA

CCTA-derived features associated with precursors of ACS or CCS

时间窗: up to 5 years after index procedure

CCTA-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 assessment

时间窗: up to 5 years after index procedure

A composite of cardiac death, vessel-related myocardial infarction (MI), or vessel-related ischemia-driven revascularization.

Change in APS detected by follow up CCTA

时间窗: up to 5 years after index procedure

Change in hemodynamic parameter of axial plaque stress (APS) detected by follow up CCTA

Change in physiological pattern by PPG derived by follow up CCTA

时间窗: up to 5 years after index procedure

Change in physiological pattern by pullback pressure gradient (PPG) derived by follow up CCTA

Change in SSI detected by follow up CCTA

时间窗: up to 5 years after index procedure

Change in stenosis susceptibility index (SSI) detected by follow up CCTA

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

时间窗: up to 5 years after index procedure

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

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

时间窗: up to 5 years after index procedure

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

Change in CT-FFR

时间窗: up to 5 years after index procedure

Change in fractional flow reserve by CCTA

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

时间窗: up to 5 years after index procedure

A composite of cardiac death, vessel-related myocardial infarction (MI), or vessel-related ischemia-driven revascularization.

次要结局

  • Number of anti-anginal medication prescribed(up to 5 years after index procedure)
  • Clinical predictors of events(up to 5 years after index procedure)
  • Prognostic value of APS(up to 5 years after index procedure)
  • Prognostic value of dCT-FFR/ds(up to 5 years after index procedure)
  • Prognostic value of per-coronary adipose tissue(up to 5 years after index procedure)
  • Prognostic value of integrated CCTA based lesion anatomy, plaque characterization, hemodynamic parameters, physiological patterns and per-coronary adipose tissue for cardiovascular events(up to 5 years after index procedure)
  • Prognostic value of WSS(up to 5 years after index procedure)
  • Prognostic value of delta CT-FFR(up to 5 years after index procedure)
  • Anginal status(up to 5 years after index procedure)
  • Prognostic value of integrated CCTA based lesion anatomy, plaque characterization, hemodynamic parameters, physiological patterns and per-coronary adipose tissue for ACS(up to 5 years after index procedure)
  • Prognostic value of pull pressure gradient(up to 5 years after index procedure)
  • Prognostic value of CCTA defined anatomy and plaque characterization(up to 5 years after index procedure)
  • Prognostic value of SSI(up to 5 years after index procedure)
  • 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 procedure)

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验