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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 (i.e., 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 (i.e., 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).
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fractional Flow Reserve | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance of FFRB to invasive FFR | 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) | 6 months from CT Angiogram |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance with FFRB for lesions of intermediate stenosis severity | 6 months from CT Angiogram | |
| Per-vessel correlation of FFRB to invasive FFR | 6 months from CT Angiogram |
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Inclusion Criteria:
Exclusion Criteria:
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132 patients scheduled to undergo clinically indicated invasive coronary angiography (ICAG) and who had CCTA performed within 180 days before the scheduled ICA, will be recruited.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soo Teik Lim, MBBS | Contact | lim.soo.teik@singhealth.com.sg | ||
| Liang Zhong, Ph.D | Contact | zhong.liang@nhcs.com.sg |
| Name | Affiliation | Role |
|---|---|---|
| Soo Teik Lim, MBBS | National Heart Centre Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Hospital | Recruiting | Singapore | 119074 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38166346 | Derived | Wang C, Leng S, Tan RS, Chai P, Fam JM, Teo LLS, Chin CY, Ong CC, Baskaran L, Keng YJF, Low AFH, Chan MY, Wong ASL, Chua SJT, Wu Q, Tan SY, Lim ST, Zhong L. Coronary CT Angiography-based Morphologic Index for Predicting Hemodynamically Significant Coronary Stenosis. Radiol Cardiothorac Imaging. 2023 Dec;5(6):e230064. doi: 10.1148/ryct.230064. |
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| ID | Term |
|---|---|
| D023921 | Coronary Stenosis |
| D002318 | Cardiovascular Diseases |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D053805 | Fractional Flow Reserve, Myocardial |
| ID | Term |
|---|---|
| D003326 | Coronary Circulation |
| D001775 | Blood Circulation |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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| National Heart Centre Singapore | Recruiting | Singapore | 169609 | Singapore |
|