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

Status unconfirmed · Not applicable

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT03864081

Run by

Analytics For Life

People needed

2500

Starts

2018-12-10

Expected to finish

2022-07-01

Last updated by the study team

2022-01-24

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Atlanta Heart Specialists — Cumming, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

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