Back to resultscPSTA System CADLAD Study (CADLAD)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Phase Signal Recorder
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring coronary angiography, ventricular ejection fraction, coronary artery disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Enrolled Subjects (PSR)
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02784197
Brief Title
cPSTA System CADLAD Study
Acronym
CADLAD
Official Title
Cardiac Phase Space Tomography Analysis (cPSTA) System: Coronary Artery Disease Learning and Development Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Analytics For Life
4. Oversight
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary angiography, ventricular ejection fraction, coronary artery disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2622 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enrolled Subjects (PSR)
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Phase Signal Recorder
Other Intervention Name(s)
PSR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Machine-learned algorithm
Description
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.
Time Frame
7 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William E Sanders, Jr., MD MBA FHRS
Organizational Affiliation
Analytics For Life
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
cPSTA System CADLAD Study
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