cPSTA System CADLAD Study

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Phase Signal Recorder

• Registration Number: NCT02784197
• Lead Sponsor: Analytics For Life

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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-24
• Study First Submitted QC: 2016-05-24
• Study First Posted: 2016-05-27
• Primary Completion: 2017-12
• Study Completion: 2018-05
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-10
• Last Update Posted: 2019-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2622

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enrolled Subjects (PSR)	Phase Signal Recorder	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.

Primary Outcome Measures

Name	Time	Method
Machine-learned algorithm	7 day	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.