Repository of Phase Signals for Algorithm Development and Testing in CAD in CHINA (CADChina)

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Diagnostic test: cPSTA

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 (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).

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients ≥ 18 years old
2. Meets criteria for coronary angiography
3. Scheduled to undergo cardiac catheterization with coronary angiography
4. Ability to understand the requirements of the study and to provide written informed consent

Exclusion Criteria:

1. Prior coronary artery bypass grafting (CABG)
2. Prior heart valve replacement
3. Previous sustained or paroxysmal atrial or ventricular arrythmia;
4. Infiltrative myocardial disease (amyloid, sarcoid, right ventricular dysplasia);
5. Presence of cardiac implantable electronic device (CIED), including implantable cardioverter defibrillator (ICD), pacemaker (PM), implantable loop recorders and other monitors
6. Implantable Neuro-stimulators
7. Congenital Heart Disease
8. Pregnant or breast feeding
9. Currently taking any Type IA, IC or III antiarrhythmics
10. Any history of amiodarone use
11. Clinically significant chest deformity (e.g., pectus excavatum or pectus carinatum)
12. Breast implants
13. Neuromuscular Disease if the condition results in tremor or muscle fasciculations

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: cPSTA GROUP; Patients who meet the study's inclusion and exclusion criteria, including signing the informed consent form, subjects will undergo cardiac Phase Space Tomography Analysis (cPSTA) signal acquisition prior to their scheduled cardiac catheterization on the day of the procedure.

Diagnostic test: cPSTA; The cPSTA System is a medical device system that uses passive tomography to analyze a patient's phase space data to identify the presence of significant coronary artery disease. The cPSTA System consists of several components that work together to obtain, transmit, analyze the data, and display the results, including the Phase Signal Acquisition System (PSAQ System), which is the Phase Signal Recorder (PSR) and the Phase Signal Data Repository (PSDR); analytical software; and secure web portal. For this study only the PSAQ System is used by the clinical site for the purposes of acquiring and transmitting the signal. All enrolled patients will perform cPSTA signal recording.; Other Names: PSR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
positive coronary artery disease	significant stenosis measured by coronary angiography	7 day after index procedure
positive cardiac Phase Space Tomography Analysis	positive result measured by cardiac Phase Space Tomography Analysis	7 day after index procedure

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Juying Qian, M.D., Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2019
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: July 21, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 26, 2019

Study Record Updates

• Last Update Posted (Actual): July 26, 2019
• Last Update Submitted That Met QC Criteria: July 25, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; ischemia; cardiac Phase Space Tomography Analysis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: CADC-CIP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No