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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Phase Signal Recorder

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 Type: Interventional
• Enrollment (Anticipated): 2500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Horace R Gillins; Phone Number: (919) 444-2843; Email: horace.gillins@analytics4life.com

Study Locations

• United States
  • Georgia
    • Cumming, Georgia, United States, 30041
      • Recruiting
      • Atlanta Heart Specialists
      • Contact: Rhonda Hamer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: Enrolled Subjects (PSR); 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.

Device: Phase Signal Recorder; 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.; Other Names: PSR

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Analytics For Life
• Investigators: Study Director: William E Sanders, Jr., MD JD LLM MBA FHRS, Analytics For Life

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 10, 2018
• Primary Completion (ANTICIPATED): July 1, 2022
• Study Completion (ANTICIPATED): July 1, 2022

Study Registration Dates

• First Submitted: January 1, 2019
• First Submitted That Met QC Criteria: March 4, 2019
• First Posted (ACTUAL): March 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 24, 2022
• Last Update Submitted That Met QC Criteria: January 21, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: coronary artery disease; coronary angiography
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: CADF-CIP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes