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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
Sponsor:
Information provided by (Responsible Party):
National Heart Centre Singapore

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 (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).

Condition or disease Intervention/treatment
Coronary Stenosis Diagnostic Test: Fractional Flow Reserve

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 (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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Study Type : Observational
Estimated Enrollment : 132 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Diagnostic performance with FFRB for lesions of intermediate stenosis severity [ Time Frame: 6 months from CT Angiogram ]
  2. Per-vessel correlation of FFRB to invasive FFR [ Time Frame: 6 months from CT Angiogram ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 98 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • Aged 21-98.
  • Underwent CCTA within 180 days and is scheduled to undergo coronary angiography and FFR in vessels having diameter stenosis between 30-90%, and deemed clinically indicated for evaluation.

Exclusion Criteria:

  • Previous PCI
  • Previous coronary artery bypass surgery
  • Contraindication to beta blockers , nitroglycerin or adenosine, including second- or third-degree heart block; sick sinus syndrome; long QT syndrome; severe hypotension; asthma, chronic obstructive pulmonary disease, heart rate <50 beats/min.
  • Acute coronary syndrome (acute myocardial infarction, unstable angina or unstable arrhythmias) is suspected.
  • Had recent myocardial infarction within 30 days before CCTA or between CCTA and coronary angiography
  • Has known complex congenital heart disease.
  • Has had pacemaker or internal defibrillator leads implanted.
  • Has a prosthetic heart valve or significant valvular pathology.
  • Has tachycardia or significant arrhythmia; heart rate ≥ 100 beats/min; systolic blood pressure ≤90 mmHg.
  • Renal dysfunction (glomerular filtration rate (GFR) <30 mL/min/1.73m2).
  • Allergy to iodinated contrast.
  • Individuals unable to provide informed consent.
  • Non-cardiac illness with life expectancy <2 years.
  • Pregnant state.
  • Canadian Cardiovascular Society class IV angina.
  • Patients with a left ventricular ejection fraction less than 30%.
  • Patients with hypertrophic cardiomyopathy.

Information from the National Library of Medicine

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


Contacts
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Contact: Soo Teik Lim, MBBS lim.soo.teik@singhealth.com.sg
Contact: Liang Zhong, Ph.D zhong.liang@nhcs.com.sg

Locations
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Singapore
National University Hospital Recruiting
Singapore, Singapore, 119074
Contact: Ping Chai, MBBS       mdccp@nus.edu.sg   
National Heart Centre Singapore Recruiting
Singapore, Singapore, 169609
Contact: Soo Teik Lim, MBBS       lim.soo.teik@singhealth.com.sg   
Principal Investigator: Soo Teik Lim, MBBS         
Sponsors and Collaborators
National Heart Centre Singapore
Investigators
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Principal Investigator: Soo Teik Lim, MBBS National Heart Centre Singapore
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Responsible Party: National Heart Centre Singapore
ClinicalTrials.gov Identifier: NCT03054324    
Other Study ID Numbers: 2016/2097
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Heart Centre Singapore:
Cardiovascular Diseases
Fractional Flow Reserve
Ischemic Heart Disease
CT Angiogram
Additional relevant MeSH terms:
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Coronary Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases