cPSTA System CADLAD Study

NCT02784197 | Completed

• 1 other identifier: BSA-CD-001
• Study Type: interventional
• Target: 2,622
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

coronary angiography; ventricular ejection fraction; coronary artery disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Enrolled Subjects (PSR)

OTHER

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

Interventions

Phase Signal Recorder DEVICE

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.

Also known as: PSR

Enrolled Subjects (PSR)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥21 years of age at the time of screening
• Meets criteria for coronary angiography
• Scheduled to undergo cardiac catheterization with coronary angiography
• Ability to understand the requirements of the study and to provide written informed consent

You may not qualify if:

• Prior documented myocardial infarction (MI)
• Prior coronary artery bypass grafting (CABG) or previous coronary interventions (PCI)
• Indication for invasive coronary angiography other than to assess for obstructive CAD (e.g., arrhythmia, cardiomyopathy, valvular abnormality)
• Previous heart valve replacement
• Previous sustained or paroxysmal atrial or ventricular arrhythmia
• Infiltrative myocardial disease (Amyloid, Sarcoid, Right ventricular dysplasia)
• Presence of cardiac implantable electronic device (CIED), including implantable cardioverter defibrillator (ICD), pacemaker (PM), implantable loop recorders and other monitors
• Implantable Neuro-stimulators
• Congenital Heart Disease
• Pregnancy (breast feeding)
• Currently taking any Type IA, IC or III antiarrhythmic
• Any history of Amiodarone therapy
• Clinically significant chest deformity (e.g., pectus excavatum or pectus carnitatum)
• Breast implants
• Neuromuscular Disease if the condition results in tremor or muscle fasciculations

Sponsors & Collaborators

• Analytics For Life: lead

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• William E Sanders, Jr., MD MBA FHRS

  Analytics For Life

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: May 27, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: May 1, 2018
• Last Updated: June 12, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share