Coronary Artery Disease Clinical Trial
Official title:
Repository of Phase Signals for Algorithm Development and Testing in Subjects With Coronary Artery Disease in China
The primary objective of this study is to build a repository of resting cardiac phase space signals from eligible subjects using the Phase Signal Recorder (PSR) prior to coronary angiography for the purposes of machine-learning and testing algorithms developed by Analytics 4 Life. Male and Female subjects will be uniquely and consecutively enrolled into one group to support populating a repository of phase signals.
Analytics 4 Life (A4L) is a medical information technology company that uses advanced signal
processing techniques for the purposes of assessing and diagnosing disease. A4L is currently
focused on developing a non-invasive solution for the assessment of significant coronary
artery disease using the cardiac Phase Space Tomography Analysis (cPSTA) System. Through
proprietary variable extraction to define phase space signals as metrics in mathematical
terms and machine learned formulas, A4L has developed a cost-effective solution to collect
and analyze phase signals as data indicative of cardiac performance. The cPSTA System
passively reconstructs and displays images from this data using topological data analysis
(TDA) to provide a computationally tractable method of interrogating the complex
physiological processes of the heart with the intent to understand and characterize the
cardiac tissue properties.
A4L has providing the Phase Signal Recorder (PSR) to the sponsor for use in this study. The
primary objective of this study is to collect resting phase signals from eligible subjects
using the Phase Space Recorder (PSR) prior to coronary angiography for the purpose of machine
learning and testing an algorithm developed to assess the presence of significant coronary
artery disease (CAD).The definition of significant CAD, which is well established in the
literature, is either the presence of a stenosis ≥50% by angiography or reduced blood flow of
<0.80as measured by Fractional Flow Rate (FFR) or instantaneous free-wave ratio (iFR)
<0.89.Each subject's CAD status will be assessing the presence of significant CAD in the
major coronary arteries including the left main artery (LMA), left anterior descending artery
(LAD), circumflex artery (LCX), and the right coronary artery (RCA) and their distributions.
Accurately assessing the presence or absence of CAD and evaluating other physiologic measures
is vital to the assessment of cardiac health/illness. As such, the following additional
assessments are planned to support further support goal: establishing a ROC curve for the
primary objective to describe a full range of sensitivity and specificity trade-offs; and,
developing and testing machine-learned algorithms to validate a clinically relevant
sensitivity and specificity for the identification of significant CAD specific to perfusion
regions (LAD, LCX, and RCA).
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