Coronary Artery DiseaseIDENTIFYNCT03864081
Non-invasive Point-of-care Diagnosis Using Machine Learning and Signal Analytics to Transform Early Detection of Heart Disease
A study testing Phase Signal Recorder in people with Coronary Artery Disease, run by Analytics For Life at 1 site in United States.
Trial summary
This study is designed as a repository study to collect resting cardiac phase signals and subject meta data from eligible subjects using the Phase Signal Recorder (PSR) prior to coronary angiography. 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
- 2,500 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2018to Jul 2022
- 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
- Patients ≥ 18 years old;
- Symptoms suggestive of obstructive CAD;
- 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 history of myocardial infarction (MI);
- Suspected acute myocardial infarction (AMI) at current presentation;
- Prior coronary artery bypass grafting (CABG);
- Prior heart valve replacement;
- Previous sustained or paroxysmal atrial or ventricular arrythmia;
- Infiltrative myocardial disease (amyloid, sarcoid, right ventricular dysplasia);
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- 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;
- Pregnant or breast feeding;
- Currently taking any Type IA, IC or III antiarrhythmics;
- Any history of amiodarone use;
- Clinically significant chest deformity (e.g., pectus excavatum or pectus carinatum);
- Breast implants;
- Neuromuscular Disease if the condition results in tremor or muscle fasciculations.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Atlanta Heart Specialists
Cumming, Georgia, 30041
Rhonda Hamer
Narendra Singh, MD
About this study
Official title: Non-Invasive Point-of-care Diagnosis Using Machine Learning and Signal Analytics to Transform Early Detection of Heart Disease
This study is designed as a repository study to collect resting cardiac phase signals and subject meta data from eligible subjects using the Phase Signal Recorder (PSR) prior to coronary angiography. The repository data will be used for the purposes of research, development, optimization and testing of machine-learning algorithms developed by Analytics 4 Life.
Read the detailed description
Male and Female subjects will be uniquely and consecutively enrolled into one of two groups to support populating a repository of phase signals: Group 1: Subjects with known prior coronary artery disease or previous percutaneous coronary intervention (PCI), and Group 2: Subjects with new onset symptoms suggestive of obstructive coronary artery disease at current presentation with no known coronary artery disease.
Enrollment into Group 1 and Group 2 will occur simultaneously until up to 500 male subjects and up to 1000 female subjects with paired data (phase signal and coronary angiography outcomes data) are enrolled. Once the desired number of subjects have been enrolled from both groups, then only Group 2 will continue to be enrolled.
Resting phase signals will be collected in all patients who meet inclusion/exclusion criteria and have signed an informed consent form. This study consists of a screening visit, resting phase signal collection (study procedure), and coronary angiography. In this study, resting phase signals will be acquired in subjects prior to coronary angiography.
- Conditions
- Coronary Artery Disease
- Being tested
- Phase Signal Recorder
- Keywords
- coronary angiography, 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 Phase Signal Acquisition (PSAQ) System is a medical device system that is being developed to collect phase signals from patients to support the development and testing of machine learned algorithms. The PSAQ System consists of two components that work together to acquire and transmit the phase signals and patient specific data to a secured, cloud-based repository. The PSAQ System is comprised of: 1) the Phase Signal Recorder (PSR) which is a portable instrument, and 2) the Phase Signal Data Repository (PSDR) which is a cloud based data repository. Data collected during this study will not be used to guide treatment.
| 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.
Phase Signal Recorder Procedure
Resting phase signals will be collected from eligible subjects prior to coronary angiography and paired with angiography results..
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 posted6 Mar 2019
- Study start10 Dec 2018
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Analytics For Life
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William E Sanders, Jr., MD JD LLM MBA FHRS, Study director, Analytics For Life
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864081
- Sponsor's protocol ID
- CADF-CIP-001
- Acronym
- IDENTIFY
- Status last verified
- Dec 2021
- First submitted
- 1 Jan 2019
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Burton T, Nemati N, Fathieh F, Gillins HR, Bridges CR, Ramchandani S, Shadforth I. Signal Acquisition, Score Interpretation, and Economics of a Non-Invasive Point-of-Care Test for Coronary Artery Disease. J Vis Exp. 2024 Aug 9;(210). doi: 10.3791/66933.
PubMed 39185859
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Point-of-care Diagnosis Using Machine Learning and Signal Analytics to Transform Early Detection of Heart Disease
- ClinicalTrials.gov ID
- NCT03864081
- Acronym / sponsor ID
- IDENTIFY / CADF-CIP-001
- Conditions
- Coronary Artery Disease
- Keywords
- coronary angiography, coronary artery disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Analytics For LifeIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 6 Mar 2019 (actual)
- 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 designed as a repository study to collect resting cardiac phase signals and subject meta data from eligible subjects using the Phase Signal Recorder (PSR) prior to coronary angiography. The repository data will be used for the purposes of research, development, optimization and testing of machine-learning algorithms developed by Analytics 4 Life.
Detailed description
Male and Female subjects will be uniquely and consecutively enrolled into one of two groups to support populating a repository of phase signals: Group 1: Subjects with known prior coronary artery disease or previous percutaneous coronary intervention (PCI), and Group 2: Subjects with new onset symptoms suggestive of obstructive coronary artery disease at current presentation with no known coronary artery disease.
Enrollment into Group 1 and Group 2 will occur simultaneously until up to 500 male subjects and up to 1000 female subjects with paired data (phase signal and coronary angiography outcomes data) are enrolled. Once the desired number of subjects have been enrolled from both groups, then only Group 2 will continue to be enrolled.
Resting phase signals will be collected in all patients who meet inclusion/exclusion criteria and have signed an informed consent form. This study consists of a screening visit, resting phase signal collection (study procedure), and coronary angiography. In this study, resting phase signals will be acquired in subjects prior to coronary angiography.
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)
- Patients ≥ 18 years old;
- Symptoms suggestive of obstructive CAD;
- 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 history of myocardial infarction (MI);
- Suspected acute myocardial infarction (AMI) at current presentation;
- Prior coronary artery bypass grafting (CABG);
- Prior heart valve replacement;
- Previous sustained or paroxysmal atrial or ventricular arrythmia;
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 Phase Signal Acquisition (PSAQ) System is a medical device system that is being developed to collect phase signals from patients to support the development and testing of machine learned algorithms. The PSAQ System consists of two components that work together to acquire and transmit the phase signals and patient specific data to a secured, cloud-based repository. The PSAQ System is comprised of: 1) the Phase Signal Recorder (PSR) which is a portable instrument, and 2) the Phase Signal Data Repository (PSDR) which is a cloud based data repository. Data collected during this study will not be used to guide treatment. | Device | Enrolled Subjects (PSR) |
Primary outcome
Phase Signal Recorder Procedure
Time frame: 7 day
Resting phase signals will be collected from eligible subjects prior to coronary angiography and paired with angiography results..
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Derived from this study: PubMed 39185859Burton T, Nemati N, Fathieh F, Gillins HR, Bridges CR, Ramchandani S, Shadforth I. Signal Acquisition, Score Interpretation, and Economics of a Non-Invasive Point-of-Care Test for Coronary Artery Disease. J Vis Exp. 2024 Aug 9;(210). doi: 10.3791/66933.
- 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 JD LLM MBA FHRS study director
Analytics For Life
1 site in 1 country: see every site and its status.
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 at 1 site in United States.
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: status not confirmed, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Horace R Gillins ((919) 444-2843, horace.gillins@analytics4life.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Signal Recorder Procedure (time frame: 7 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03864081, which also lists 1 linked publication.
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 24 Jan 2022.