Ignite Creation Date:
2024-05-06 @ 9:44 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03054324
Status:
UNKNOWN
Last Update Posted:
2018-10-18
First Post:
2017-02-06
Brief Title:
Validation of a Predictive Model of Coronary Fractional Flow Reserve in Patients With Intermediate Coronary Stenosis
Sponsor:
National Heart Centre Singapore
Organization:
National Heart Centre Singapore
Study Overview
Official Title:
FFRB Study Validation of a Predictive Model of Coronary Fractional Flow Reserve in Patients With Intermediate Coronary Stenosis
Status:
UNKNOWN
Status Verified Date:
2018-03
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:
FFRB
Brief Summary:
Coronary fraction flow reserve FFR the ratio of the mean coronary pressure distal to a coronary stenosis to the mean aortic pressure during maximal coronary blood flow hyperemia defines the hemodynamic significance of coronary artery narrowing Noninvasive assessment of FFR via a combination of computational fluid dynamics CFD and coronary CT angiography CCTA the so-called FFRCT has potential Coronary computed tomographic angiography is a noninvasive test for diagnosis of anatomic coronary stenosis ie narrowing of a blood vessel A new analytical model of FFR from the general Bernoulli equation conservation of energy FFRB is simple and has potential A collaborator group has recently developed a new analytical model to quantify pressure drop and hence FFR based on lesion dimensions ie the cross-section area along the lesion and the length of lesion and coronary flow with no empirical parameters The investigators hypothesize that this new model will allow quantification of FFR FFRB in a cohort of human patients with intermediate coronary stenosis The study will compare FFRB with invasive FFR measurements from invasive coronary angiography ICAG
Detailed Description:
Coronary fraction flow reserve FFR the ratio of the mean coronary pressure distal to a coronary stenosis to the mean aortic pressure during maximal coronary blood flow hyperemia defines the hemodynamic significance of coronary artery narrowing Recent landmark studies showed a clear benefit of FFR in guiding percutaneous coronary intervention PCI for better clinical outcome and cost-effectiveness The reference method for FFR measurement requires the use of a pressure wire inserted across the stenosis invasively Therefore a non-invasive method to quantify FFR is clinically desired
Noninvasive assessment of FFR via a combination of computational fluid dynamics CFD and coronary CT angiography CCTA the so-called FFRCT has potential Coronary computed tomographic angiography is a noninvasive test for diagnosis of anatomic coronary stenosis ie narrowing of a blood vessel However CCTA alone does not determine whether a stenosis causes ischemia Computational fluid dynamics CFD applied to CCTA images enables computation of FFR FFRCT Recent studies have demonstrated the potential of FFRCT as a promising noninvasive method for identification of individual lesion with ischemia from both single centre and multi-centre prospective studies However the FFRCT is currently performed remotely and it takes several hours to complete the computation for each study This potentially impedes the wider clinical application of FFRCT
A new analytical model of FFR from the general Bernoulli equation conservation of energy FFRB is simple and has potential The Bernoulli equation has many clinical applications A collaborator group has recently developed a new analytical model to quantify pressure drop and hence FFR based on lesion dimensions ie the cross-section area along the lesion and the length of lesion and coronary flow with no empirical parameters The investigators validated it using in vitro and in vivo experiments and finite-element method The study team hypothesize that this new model will allow quantification of FFR FFRB in a cohort of human patients with intermediate coronary stenosis The investigators will compare FFRB with invasive FFR measurements from invasive coronary angiography ICAG
Aims and Objectives
Primary aim Diagnostic performance of FFRB with CCTA data in patients with intermediate coronary artery disease CAD as compared to an invasive FFR reference standard FFR080
Secondary aims Diagnostic performance with FFRB for lesions of intermediate stenosis severity Determining the per-vessel correlation of FFRB value to FFR from ICA
Noninvasive assessment of FFR via a combination of computational fluid dynamics CFD and coronary CT angiography CCTA the so-called FFRCT has potential Coronary computed tomographic angiography is a noninvasive test for diagnosis of anatomic coronary stenosis ie narrowing of a blood vessel However CCTA alone does not determine whether a stenosis causes ischemia Computational fluid dynamics CFD applied to CCTA images enables computation of FFR FFRCT Recent studies have demonstrated the potential of FFRCT as a promising noninvasive method for identification of individual lesion with ischemia from both single centre and multi-centre prospective studies However the FFRCT is currently performed remotely and it takes several hours to complete the computation for each study This potentially impedes the wider clinical application of FFRCT
A new analytical model of FFR from the general Bernoulli equation conservation of energy FFRB is simple and has potential The Bernoulli equation has many clinical applications A collaborator group has recently developed a new analytical model to quantify pressure drop and hence FFR based on lesion dimensions ie the cross-section area along the lesion and the length of lesion and coronary flow with no empirical parameters The investigators validated it using in vitro and in vivo experiments and finite-element method The study team hypothesize that this new model will allow quantification of FFR FFRB in a cohort of human patients with intermediate coronary stenosis The investigators will compare FFRB with invasive FFR measurements from invasive coronary angiography ICAG
Aims and Objectives
Primary aim Diagnostic performance of FFRB with CCTA data in patients with intermediate coronary artery disease CAD as compared to an invasive FFR reference standard FFR080
Secondary aims Diagnostic performance with FFRB for lesions of intermediate stenosis severity Determining the per-vessel correlation of FFRB value to FFR from ICA
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