Clinical trial NCT02784197: cPSTA System CADLAD Study
Official title: Cardiac Phase Space Tomography Analysis (cPSTA) System: Coronary Artery Disease Learning and Development Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: coronary angiography
ventricular ejection fraction
coronary artery disease
Lead sponsor: Analytics For Life
Sponsor class: INDUSTRY
First posted: 2016-05-27
Enrollment: 2622
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Machine-learned algorithm
timeFrame: 7 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Analytics For Life
name: William E Sanders, Jr., MD MBA FHRS
role: STUDY_DIRECTOR
References: