cPSTA System CADLAD Study

NCT ID: NCT02784197

Last Updated: 2019-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2622 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2018-05-31

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.

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Phase Signal Recorder

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

PSR

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Analytics For Life

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William E Sanders, Jr., MD MBA FHRS

Role: STUDY_DIRECTOR

Analytics For Life

Other Identifiers

BSA-CD-001

Identifier Type: -

Identifier Source: org_study_id