Validation of a Predictive Model of Coronary Fractional Flow Reserve in Patients With Intermediate Coronary Stenosis
FFRB
FFRB Study: Validation of a Predictive Model of Coronary Fractional Flow Reserve in Patients With Intermediate Coronary Stenosis
1 other identifier
observational
132
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2016
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 2, 2016
CompletedFirst Submitted
Initial submission to the registry
February 6, 2017
CompletedFirst Posted
Study publicly available on registry
February 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedOctober 18, 2018
March 1, 2018
2.3 years
February 6, 2017
October 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
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
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
National University Hospital
Singapore, 119074, Singapore
National Heart Centre Singapore
Singapore, 169609, Singapore
Related Publications (1)
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.
PMID: 38166346DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Soo Teik Lim, MBBS
National Heart Centre Singapore
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2017
First Posted
February 15, 2017
Study Start
September 2, 2016
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
October 18, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share