Ignite Creation Date:
2024-05-06 @ 5:40 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05380622
Status:
RECRUITING
Last Update Posted:
2022-05-25
First Post:
2022-05-10
Brief Title:
CHART Study of Coronary CT Angiography in Coronary Artery Disease
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Shanghai Zhongshan Hospital
Study Overview
Official Title:
CHART Study of Coronary CT Angiography to Predict Imaging and Cardiovascular Outcomes in Patients With Coronary Artery Disease
Status:
RECRUITING
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHART-VISION
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
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 FFR080 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-FFRds 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 withwithout 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
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-FFRds 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 withwithout 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None