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).
Study Type
OBSERVATIONAL
Enrollment
350
UC San Diego Health - Sulpizio Cardiovascular Center/ACTRI 2W502-A10
La Jolla, California, United States
RECRUITINGUniversity of California, San Francisco
San Francisco, California, United States
RECRUITINGUCSF - Parnassas
San Francisco, California, United States
RECRUITINGWellstar Research Institute
Marietta, Georgia, United States
RECRUITINGBaylor College of Medicine
Houston, Texas, United States
RECRUITINGUniversity of Wisconsin School of Medicine & Public Health
Madison, Wisconsin, United States
RECRUITINGDiagnostic performance of the Infrasensor for detection of high-grade obstructive NSTE-ACS
Sensitivity and specificity (with lower bound of the two-sided 95% confidence interval) of the Infrasensor for identification of high-grade obstructive non-ST-segment elevation acute coronary syndrome (NSTE-ACS), compared with angiographic diagnosis of high-grade obstructive coronary artery disease (CAD). High-grade obstructive CAD is defined as \>50% stenosis in the left main coronary artery or \>70% stenosis in one or more major coronary arteries and/or revascularization.
Time frame: Baseline (ED presentation) through hospital discharge, up to 30 days
Additional diagnostic performance metrics of the Infrasensor
Positive predictive value (PPV), negative predictive value (NPV), and overall accuracy of the Infrasensor for detection of high-grade obstructive NSTE-ACS compared with angiographic diagnosis.
Time frame: Baseline (ED presentation) through hospital discharge, up to 30 days
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