Coronary Artery DiseaseCADLADNCT02784197
cPSTA System CADLAD Study
A study testing Phase Signal Recorder in people with Coronary Artery Disease, run by Analytics For Life.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Phase Signal Recorder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,622 participants
- Where
- No sites listed yet
- Study dates
- May 2016to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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
About this study
Official title: Cardiac Phase Space Tomography Analysis (cPSTA) System: Coronary Artery Disease Learning and Development Study
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.
Read the 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
- Being tested
- Phase Signal Recorder
- Keywords
- coronary angiography, ventricular ejection fraction, coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase Signal RecorderDevice
Also called PSR
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Phase Signal Recorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2017
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,622 participants (actual)
Sponsor and investigators
- Lead sponsor
- Analytics For Life
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William E Sanders, Jr., MD MBA FHRS, Study director, Analytics For Life
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784197
- Sponsor's protocol ID
- BSA-CD-001
- Acronym
- CADLAD
- Status last verified
- Jun 2019
- First submitted
- 24 May 2016
- Last updated
- 12 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Phase Space Tomography Analysis (cPSTA) System: Coronary Artery Disease Learning and Development Study
- ClinicalTrials.gov ID
- NCT02784197
- Acronym / sponsor ID
- CADLAD / BSA-CD-001
- Conditions
- Coronary Artery Disease
- Keywords
- coronary angiography, ventricular ejection fraction, coronary artery disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,622 participants (actual)
- Lead sponsor
- Analytics For LifeIndustry (pharma, biotech, devices)
- Study start
- May 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 27 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled Subjects (PSR) | Other | Device: Phase Signal RecorderPatients 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phase Signal RecorderAlso: PSRThe 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. | Device | Enrolled Subjects (PSR) |
Primary outcome
Machine-learned algorithm
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William E Sanders, Jr., MD MBA FHRS study director
Analytics For Life
Questions about this trial
What is this clinical trial studying?
A study testing Phase Signal Recorder in people with Coronary Artery Disease, run by Analytics For Life.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Machine-learned algorithm (time frame: 7 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2019.