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

NCT03864081 | Unknown FDA Device

• 1 other identifier: CADF-CIP-001
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

coronary angiography; coronary artery disease

Outcome Measures

Primary Outcomes (1)

• Phase Signal Recorder Procedure

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

  7 day

Study Arms (1)

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.

Device: Phase Signal Recorder

Interventions

Phase Signal Recorder DEVICE

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.

Also known as: PSR

Enrolled Subjects (PSR)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Analytics For Life: lead

Study Sites (1)

Atlanta Heart Specialists

Cumming, Georgia, 30041, United States

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• William E Sanders, Jr., MD JD LLM MBA FHRS

  Analytics For Life

  STUDY DIRECTOR

Central Study Contacts

Horace R Gillins

CONTACT

(919) 444-2843; horace.gillins@analytics4life.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2019
• First Posted: March 6, 2019
• Study Start: December 10, 2018
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: January 24, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)