Infrasensor for Early Identification of High-grade Obstructive Non-ST-segment Elevation Acute Coronary Syndrome in Patients With Suspected Acute Coronary Syndrome
Remote Cardiac Enablement
Summary
The objective of this prospective, cross-sectional, multicenter pivotal trial study is to validate Infrasensor's clinical performance for the detection of high grade obstructive NSTE-ACS. High-grade obstructive NSTE-ACS is defined as an acute coronary syndrome in which severe obstructive coronary artery disease, including total coronary artery occlusion is present. Study Endpoints Primary Endpoint: Infrasensor performance (Lower bound of 95% CI for sensitivity, specificity) between device detection of high-grade obstructive NSTE-ACS and angiographic diagnosis of High-grade obstructive CAD defined as the aggregate of \>50% left main stenosis, or \>70% stenosis in 1 or more coronary arteries and/or emergent revascularization. Secondary Endpoint: Infrasensor performance (positive and negative predictive values, and overall accuracy).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subject is willing and able to sign an Informed Consent * Age: ≥18 years * Study subjects with symptoms suggestive of ACS within 24 hours of presentation in an emergency department or acute care setting in whom invasive coronary angiography is intended. * The following conditions for Infrasensor use must be present: The Infrasensor should only be used on alert patients who are able to keep the device still for the 5 minute measurement duration, who have clean, intact skin at the measurement site, and who do not have blood pressure cuffs, IV lines, or other medical equipm…