Ignite Creation Date:
2024-05-06 @ 3:00 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04493086
Status:
UNKNOWN
Last Update Posted:
2020-07-30
First Post:
2020-07-28
Brief Title:
Effect of FFRCT-angio in Functional Diagnosis of Coronary Artery Stenosis
Sponsor:
First Affiliated Hospital of Harbin Medical University
Organization:
First Affiliated Hospital of Harbin Medical University
Study Overview
Official Title:
Effect of FFRCT-angio in Functional Diagnosis of Coronary Artery Stenosis a Prospective Multicenter Clinical Study
Status:
UNKNOWN
Status Verified Date:
2020-07
Last Known Status:
RECRUITING
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:
None
Brief Summary:
Coronary CT angiography CTA or invasive coronary angiography CAG is usually performed to evaluate the severity of coronary stenosis depending on the probability of CAD However the stenosis severity is not closely corresponding with the hemodynamic significance in coronary arteries
As a result fractional flow reserve FFR with pressure wire measurement was introduced to functionally assess the coronary stenosis FFR is defined as the ratio of maximum blood flow distal to a stenotic lesion under hyperemia state to normal maximum flow in the same vessel The cutoff value of FFR to detect significant ischemia is set to be 080 indicating that PCI should be considered if FFR080 However FFR does have some limitations such as risks of pressure wire injury extra time and cost and side effects of hyperemic agents
To overcome the limitations of FFR CTA- and CAG-based methods to functionally assess coronary stenosis were proposed ie FFR derived from CTA FFRCT and FFR derived from angiography-based quantitative flow ratio QFR which can simultaneously evaluate anatomic and hemodynamic significance of stenotic lesions A number of studies have demonstrated that FFRCT has high sensitivity and specificity in identifying myocardial ischemia However the diagnostic accuracy of FFRCT depends on the image quality of coronary CTA and it is relatively low in lesions with severe calcification andor tortuosity Besides the methodology of FFRCT relies on computational fluid dynamics which is complicated and time consuming As for QFR it is a novel method for deriving FFR based on 3-dimensional quantitative coronary angiography 3D-QCA and contrast frame counting during CAG Recent studies have shown that QFR has good diagnostic performance in evaluating the functional significance of coronary stenosis The accuracy of QFR is also highly associated with anatomic information thereby its diagnostic accuracy may be decreased in diffuse tandem thrombus-containing calcified or torturous lesions and it is not suitable for prior infarction-related or collateral donor arteries as well Given the above issues concerning FFRCT and QFR we proposed a novel approach that integrates coronary CTA and CAG images to calculate FFR FFRCT-angio using artificial intelligence The present study was undertaken to test the diagnostic accuracy of FFRCT-angio in patients with SCAD
As a result fractional flow reserve FFR with pressure wire measurement was introduced to functionally assess the coronary stenosis FFR is defined as the ratio of maximum blood flow distal to a stenotic lesion under hyperemia state to normal maximum flow in the same vessel The cutoff value of FFR to detect significant ischemia is set to be 080 indicating that PCI should be considered if FFR080 However FFR does have some limitations such as risks of pressure wire injury extra time and cost and side effects of hyperemic agents
To overcome the limitations of FFR CTA- and CAG-based methods to functionally assess coronary stenosis were proposed ie FFR derived from CTA FFRCT and FFR derived from angiography-based quantitative flow ratio QFR which can simultaneously evaluate anatomic and hemodynamic significance of stenotic lesions A number of studies have demonstrated that FFRCT has high sensitivity and specificity in identifying myocardial ischemia However the diagnostic accuracy of FFRCT depends on the image quality of coronary CTA and it is relatively low in lesions with severe calcification andor tortuosity Besides the methodology of FFRCT relies on computational fluid dynamics which is complicated and time consuming As for QFR it is a novel method for deriving FFR based on 3-dimensional quantitative coronary angiography 3D-QCA and contrast frame counting during CAG Recent studies have shown that QFR has good diagnostic performance in evaluating the functional significance of coronary stenosis The accuracy of QFR is also highly associated with anatomic information thereby its diagnostic accuracy may be decreased in diffuse tandem thrombus-containing calcified or torturous lesions and it is not suitable for prior infarction-related or collateral donor arteries as well Given the above issues concerning FFRCT and QFR we proposed a novel approach that integrates coronary CTA and CAG images to calculate FFR FFRCT-angio using artificial intelligence The present study was undertaken to test the diagnostic accuracy of FFRCT-angio in patients with SCAD
Detailed Description:
Cardiovascular disease remains the leading cause of death worldwide and stable coronary artery disease SCAD accounts for the greatest proportion of cardiovascular disease In the past decades percutaneous coronary intervention PCI has become one of the most common treatments for SCAD and therefore assessing the hemodynamic significance of coronary stenosis is important for physicians to make the optimal treating strategy Coronary CT angiography CTA or invasive coronary angiography CAG is usually performed to evaluate the severity of coronary stenosis depending on the probability of CAD However the stenosis severity is not closely corresponding with the hemodynamic significance in coronary arteries
As a result fractional flow reserve FFR with pressure wire measurement was introduced to functionally assess the coronary stenosis FFR is defined as the ratio of maximum blood flow distal to a stenotic lesion under hyperemia state to normal maximum flow in the same vessel The cutoff value of FFR to detect significant ischemia is set to be 080 indicating that PCI should be considered if FFR080 FAME Fractional Flow Reserve versus Angiography for Multivessel Evaluation study confirmed that FFR guided PCI was superior to angiography guided PCI in reducing major adverse cardiovascular events MACE in patients with multivessel disease In the subsequent FAME 2 study FFR guided PCI plus the optimal medical treatment OMT as compared with the OMT alone decreased the composite event rates mainly driven by urgent revascularization in SCAD patients However FFR does have some limitations such as risks of pressure wire injury extra time and cost and side effects of hyperemic agents
To overcome the limitations of FFR CTA- and CAG-based methods to functionally assess coronary stenosis were proposed ie FFR derived from CTA FFRCT and FFR derived from angiography-based quantitative flow ratio QFR which can simultaneously evaluate anatomic and hemodynamic significance of stenotic lesions A number of studies have demonstrated that FFRCT has high sensitivity and specificity in identifying myocardial ischemia However the diagnostic accuracy of FFRCT depends on the image quality of coronary CTA and it is relatively low in lesions with severe calcification andor tortuosity Besides the methodology of FFRCT relies on computational fluid dynamics which is complicated and time consuming As for QFR it is a novel method for deriving FFR based on 3-dimensional quantitative coronary angiography 3D-QCA and contrast frame counting during CAG Recent studies have shown that QFR has good diagnostic performance in evaluating the functional significance of coronary stenosis The accuracy of QFR is also highly associated with anatomic information thereby its diagnostic accuracy may be decreased in diffuse tandem thrombus-containing calcified or torturous lesions and it is not suitable for prior infarction-related or collateral donor arteries as well Given the above issues concerning FFRCT and QFR we proposed a novel approach that integrates coronary CTA and CAG images to calculate FFR FFRCT-angio using artificial intelligence The present study was undertaken to test the diagnostic accuracy of FFRCT-angio in patients with SCAD
As a result fractional flow reserve FFR with pressure wire measurement was introduced to functionally assess the coronary stenosis FFR is defined as the ratio of maximum blood flow distal to a stenotic lesion under hyperemia state to normal maximum flow in the same vessel The cutoff value of FFR to detect significant ischemia is set to be 080 indicating that PCI should be considered if FFR080 FAME Fractional Flow Reserve versus Angiography for Multivessel Evaluation study confirmed that FFR guided PCI was superior to angiography guided PCI in reducing major adverse cardiovascular events MACE in patients with multivessel disease In the subsequent FAME 2 study FFR guided PCI plus the optimal medical treatment OMT as compared with the OMT alone decreased the composite event rates mainly driven by urgent revascularization in SCAD patients However FFR does have some limitations such as risks of pressure wire injury extra time and cost and side effects of hyperemic agents
To overcome the limitations of FFR CTA- and CAG-based methods to functionally assess coronary stenosis were proposed ie FFR derived from CTA FFRCT and FFR derived from angiography-based quantitative flow ratio QFR which can simultaneously evaluate anatomic and hemodynamic significance of stenotic lesions A number of studies have demonstrated that FFRCT has high sensitivity and specificity in identifying myocardial ischemia However the diagnostic accuracy of FFRCT depends on the image quality of coronary CTA and it is relatively low in lesions with severe calcification andor tortuosity Besides the methodology of FFRCT relies on computational fluid dynamics which is complicated and time consuming As for QFR it is a novel method for deriving FFR based on 3-dimensional quantitative coronary angiography 3D-QCA and contrast frame counting during CAG Recent studies have shown that QFR has good diagnostic performance in evaluating the functional significance of coronary stenosis The accuracy of QFR is also highly associated with anatomic information thereby its diagnostic accuracy may be decreased in diffuse tandem thrombus-containing calcified or torturous lesions and it is not suitable for prior infarction-related or collateral donor arteries as well Given the above issues concerning FFRCT and QFR we proposed a novel approach that integrates coronary CTA and CAG images to calculate FFR FFRCT-angio using artificial intelligence The present study was undertaken to test the diagnostic accuracy of FFRCT-angio in patients with SCAD
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