Validation of a Predictive Model of Coronary Fractional Flow Reserve in Patients With Intermediate Coronary Stenosis (FFRB)
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|ClinicalTrials.gov Identifier: NCT03054324|
Recruitment Status : Unknown
Verified March 2018 by National Heart Centre Singapore.
Recruitment status was: Recruiting
First Posted : February 15, 2017
Last Update Posted : October 18, 2018
|Condition or disease||Intervention/treatment|
|Coronary Stenosis||Diagnostic Test: Fractional Flow Reserve|
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 (i.e., 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 (i.e., 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 (FFR<=0.80)
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 Type :||Observational|
|Estimated Enrollment :||132 participants|
|Official Title:||FFRB Study: Validation of a Predictive Model of Coronary Fractional Flow Reserve in Patients With Intermediate Coronary Stenosis|
|Actual Study Start Date :||September 2, 2016|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2018|
- Diagnostic Test: Fractional Flow Reserve
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.
- Diagnostic performance of FFRB to invasive FFR [ Time Frame: 6 months from CT Angiogram ]The diagnostic performance of FFRB with CCTA data in patients with intermediate coronary artery disease (CAD), as compared to an invasive FFR reference standard (FFR<=0.80)
- Diagnostic performance with FFRB for lesions of intermediate stenosis severity [ Time Frame: 6 months from CT Angiogram ]
- Per-vessel correlation of FFRB to invasive FFR [ Time Frame: 6 months from CT Angiogram ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054324
|Contact: Soo Teik Lim, MBBSfirstname.lastname@example.org|
|Contact: Liang Zhong, Ph.Demail@example.com|
|National University Hospital||Recruiting|
|Singapore, Singapore, 119074|
|Contact: Ping Chai, MBBS firstname.lastname@example.org|
|National Heart Centre Singapore||Recruiting|
|Singapore, Singapore, 169609|
|Contact: Soo Teik Lim, MBBS email@example.com|
|Principal Investigator: Soo Teik Lim, MBBS|
|Principal Investigator:||Soo Teik Lim, MBBS||National Heart Centre Singapore|