cPSTA System CADLAD Study (CADLAD)

Cardiac Phase Space Tomography Analysis (cPSTA) System: Coronary Artery Disease Learning and Development Study

This study is primarily designed to collect resting phase signals from eligible subjects using the Phase Signal Recorder (PSR) prior to coronary angiography to machine learn and test an algorithm for detecting the presence of significant coronary artery disease in symptomatic adult patient.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Phase Signal Recorder

Detailed Description

This clinical protocol is primarily designed to collect resting phase signals from eligible subjects using the Phase Signal Recorder (PSR) prior to coronary angiography to machine learn and test an algorithm for detecting the presence of significant coronary artery disease in symptomatic adult patient. In addition to this primary objective, machine-learned algorithms will be developed and tested to report the left ventricular ejection fraction and to identify the location of significant coronary artery disease. The performance of the machine-learned algorithm will be evaluated using a comparative paired trial design. In this study, the physician will not be provided the results of analysis performed and, accordingly, the results of the analyses will not be used to guide treatment decisions for the patient.

• Study Type: Interventional
• Enrollment (Actual): 2622
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥21 years of age at the time of screening
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 documented myocardial infarction (MI)
2. Prior coronary artery bypass grafting (CABG) or previous coronary interventions (PCI)
3. Indication for invasive coronary angiography other than to assess for obstructive CAD (e.g., arrhythmia, cardiomyopathy, valvular abnormality)
4. Previous heart valve replacement
5. Previous sustained or paroxysmal atrial or ventricular arrhythmia
6. Infiltrative myocardial disease (Amyloid, Sarcoid, Right ventricular dysplasia)
7. Presence of cardiac implantable electronic device (CIED), including implantable cardioverter defibrillator (ICD), pacemaker (PM), implantable loop recorders and other monitors
8. Implantable Neuro-stimulators
9. Congenital Heart Disease
10. Pregnancy (breast feeding)
11. Currently taking any Type IA, IC or III antiarrhythmic
12. Any history of Amiodarone therapy
13. Clinically significant chest deformity (e.g., pectus excavatum or pectus carnitatum)
14. Breast implants
15. 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

Other: Enrolled Subjects (PSR); Patients who meet the study's inclusion and exclusion criteria, including signing the informed consent form, subjects will undergo signal acquisition prior to their scheduled cardiac catheterization on the day of the procedure.

Device: Phase Signal Recorder; 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.; Other Names: PSR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Machine-learned algorithm	Develop and test a machine-learned algorithm which maximizes the area under the receiver-operating characteristic (AUC-ROC) curve to 0.70 (expected) and clinically significant sensitivity and specificity to detect CAD when compared to clinical diagnosis of significant coronary artery disease (i.e., presence of ≥70% stenosis by angiography or reduced fraction flow of <=0.80) in at least one of the major coronary arteries (LMA, LAD, RCA, or LCX) or their distributions.	7 day

Collaborators and Investigators

• Sponsor: Analytics For Life
• Investigators: Study Director: William E Sanders, Jr., MD MBA FHRS, Analytics For Life

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: May 24, 2016
• First Submitted That Met QC Criteria: May 24, 2016
• First Posted (Estimate): May 27, 2016

Study Record Updates

• Last Update Posted (Actual): June 12, 2019
• Last Update Submitted That Met QC Criteria: June 10, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: coronary artery disease; coronary angiography; ventricular ejection fraction
• 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: BSA-CD-001

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No