Ignite Creation Date:
2024-05-06 @ 1:27 PM
Last Modification Date:
2024-10-26 @ 1:15 PM
Study NCT ID:
NCT04034537
Status:
UNKNOWN
Last Update Posted:
2019-07-26
First Post:
2019-07-21
Brief Title:
Repository of Phase Signals for Algorithm Development and Testing in CAD in CHINA
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Shanghai Zhongshan Hospital
Study Overview
Official Title:
Repository of Phase Signals for Algorithm Development and Testing in Subjects With Coronary Artery Disease in China
Status:
UNKNOWN
Status Verified Date:
2019-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CADChina
Brief Summary:
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
Detailed Description:
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 CADThe 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 080as measured by Fractional Flow Rate FFR or instantaneous free-wave ratio iFR 089Each subjects 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 healthillness 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
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 CADThe 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 080as measured by Fractional Flow Rate FFR or instantaneous free-wave ratio iFR 089Each subjects 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 healthillness 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None