Status:
UNKNOWN
Non-invasive Point-of-care Diagnosis Using Machine Learning and Signal Analytics to Transform Early Detection of Heart Disease
Lead Sponsor:
Analytics For Life
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
21+ years
Phase:
NA
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. ...
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 dise...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
2500 Patients enrolled
Trial Details
Trial ID
NCT03864081
Start Date
December 10 2018
End Date
July 1 2022
Last Update
January 24 2022
Active Locations (1)
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1
Atlanta Heart Specialists
Cumming, Georgia, United States, 30041