search
Back to results

Non-invasive Point-of-care Diagnosis Using Machine Learning and Signal Analytics to Transform Early Detection of Heart Disease (IDENTIFY)

Primary Purpose

Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phase Signal Recorder
Sponsored by
Analytics For Life
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring coronary angiography, coronary artery disease

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients ≥ 18 years old;
  2. Symptoms suggestive of obstructive CAD;
  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 history of myocardial infarction (MI);
  2. Suspected acute myocardial infarction (AMI) at current presentation;
  3. Prior coronary artery bypass grafting (CABG);
  4. Prior heart valve replacement;
  5. Previous sustained or paroxysmal atrial or ventricular arrythmia;
  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. Pregnant or breast feeding;
  11. Currently taking any Type IA, IC or III antiarrhythmics;
  12. Any history of amiodarone use;
  13. Clinically significant chest deformity (e.g., pectus excavatum or pectus carinatum);
  14. Breast implants;
  15. Neuromuscular Disease if the condition results in tremor or muscle fasciculations.

Sites / Locations

  • Atlanta Heart SpecialistsRecruiting

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

Phase Signal Recorder Procedure
Resting phase signals will be collected from eligible subjects prior to coronary angiography and paired with angiography results..

Secondary Outcome Measures

Full Information

First Posted
January 1, 2019
Last Updated
January 21, 2022
Sponsor
Analytics For Life
search

1. Study Identification

Unique Protocol Identification Number
NCT03864081
Brief Title
Non-invasive Point-of-care Diagnosis Using Machine Learning and Signal Analytics to Transform Early Detection of Heart Disease
Acronym
IDENTIFY
Official Title
Non-Invasive Point-of-care Diagnosis Using Machine Learning and Signal Analytics to Transform Early Detection of Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 10, 2018 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Analytics For Life

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

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, 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
2500 (Anticipated)

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 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.
Primary Outcome Measure Information:
Title
Phase Signal Recorder Procedure
Description
Resting phase signals will be collected from eligible subjects prior to coronary angiography and paired with angiography results..
Time Frame
7 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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); 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Horace R Gillins
Phone
(919) 444-2843
Email
horace.gillins@analytics4life.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William E Sanders, Jr., MD JD LLM MBA FHRS
Organizational Affiliation
Analytics For Life
Official's Role
Study Director
Facility Information:
Facility Name
Atlanta Heart Specialists
City
Cumming
State/Province
Georgia
ZIP/Postal Code
30041
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rhonda Hamer
First Name & Middle Initial & Last Name & Degree
Narendra Singh, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Non-invasive Point-of-care Diagnosis Using Machine Learning and Signal Analytics to Transform Early Detection of Heart Disease

We'll reach out to this number within 24 hrs