Coronary Artery Disease Clinical Trial
Official title:
The First Experience With Using a One-dimensional Mathematical Model With Fully Automated Algorithm of Extraction of Patient-specific Geometry From CT Images for a Noninvasive Assessment of Fractional Flow Reserve.
This study evaluates the diagnostic efficiency of an automated method of noninvasive
assessment of the fractional reserve of coronary blood flow.
Fractional flow reserve is estimated with a one-dimensional mathematical model constructed by
means of an automated algorithm. Noninvasive method values are thereafter compared with
invasive method values.
Noninvasive assessment of Fractional Flow Reserve is almost never applied in the Russian
Federation due to the relative novelty and study insufficiency, lack of the appropriate
resource base, specific necessary software and trained qualified personnel.
In 2015, scientists from the Institute of Numerical Mathematics RAS in collaboration with
specialists of the I.M. Sechenov First Moscow State Medical University developed a
noninvasive method of fractional flow reserve assessment based on a one-dimensional
mathematical model. A model is constructed based on images derived from the coronary computed
tomography angiography performed by standard protocol; the method is fully automated.
The aim of our study is to evaluate the diagnostic efficiency of this technique in clinical
practice.
This is a pilot study; we are planning to enroll 30 patients: 13 of them underwent 64-slice
computed tomography and are included retrospectively; 17 will be included prospectively, with
a 640-slice CT scan. Specialists from the Laboratory of Mathematical Modeling will process CT
images and evaluate noninvasive FFR. Ischemia is confirmed if FFR < 0.80 and disproved if FFR
≥ 0.80. After that, the prospective group of patients will be hospitalized for invasive FFR
assessment as a reference standard; if ischemia is proved, patients will undergo stent
implantation. In the retrospective group, patients already have invasive FFR values
estimated.
Statistical analysis will be performed using R programming language packages
(cran-r.project.com). Continuous variables will be presented as mean values ± standard
deviations, order variables will be presented as medians with interquartile ranges in
parentheses. We are going to use the D'Agostino-Pearson omnibus test for the assessment of
normality of distribution and construct a Q-Q Plot. We will compare these two methods with
the Bland-Altman analysis and ROC-analysis and will assess the degree of correlation with the
Pearson's chi-squared.
The study should result in determining the sensitivity, specificity, positive and negative
predictive values of the method.
After the active phase of the research is done, we are planning to proceed observation on the
prospective group of patients to verify the endpoints.
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