Recruiting

Heart Disease Detection

Sponsor:

Analytics For Life

Code:

NCT03864081

Conditions

Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Phase Signal Recorder

Study Details

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

Study ID

NCT03864081

Start date

Dec 10, 2018

Status verified date

Dec, 2021

Completion date

Jul, 2022

Anticipated

Primary completion date

Jul, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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 Design

Enrollment

2500 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Phase Signal Recorder Procedure [ Time Frame: 7 day ]

Central Contacts and Locations

Central contacts

Locations

Atlanta Heart Specialists

Recruiting

Cumming, Georgia, United States, 30041

Principal Investigator:

Narendra Singh, MD

More Information

Sponsor

Analytics For Life

Last update posted

Jan 24, 2022

Last verified

Dec, 2021

Keywords

  • coronary angiography
  • coronary artery disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Analytics For Life on 2022-01-24.