Validation of a Predictive Model of Coronary Fractional Flow Reserve in Patients With Intermediate Coronary Stenosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

132 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-02

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of the Diagnostic Performance and Costs of FFRB Vs. Standard Care in Suspected Coronary Artery Disease.

NCT06681584

Coronary Artery Disease Cardiovascular Diseases Cardiovascular; Stenosis +6 more

ACTIVE_NOT_RECRUITING

Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation

NCT02053038

Coronary Artery Disease

UNKNOWN NA

Clinical Usefulness of Fractional Flow Reserve Measurement for Significant Stenosis in Proximal Coronary Artery

NCT02475291

Coronary Artery Disease Stenosis

COMPLETED

Pronostic Impact of Flow Fraction Reserve on Intermediate Stenoses

NCT03588455

Coronary Stenosis

COMPLETED

A Prospective Study of Fractional Flow Reserve Assessment of Intermediate Coronary Stenoses in Severe Aortic Stenosis

NCT03442400

Coronary Artery Stenoses Aortic Stenosis

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Stenosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

98 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No