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Infrasensor for Early Detection of a High-grade Obstructive NSTE-ACS
Sponsor: 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).
Official title: Infrasensor for Early Identification of High-grade Obstructive Non-ST-segment Elevation Acute Coronary Syndrome in Patients With Suspected Acute Coronary Syndrome
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
350
Start Date
2025-12-30
Completion Date
2026-07
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Locations (6)
UC San Diego Health - Sulpizio Cardiovascular Center/ACTRI 2W502-A10
La Jolla, California, United States
University of California, San Francisco
San Francisco, California, United States
UCSF - Parnassas
San Francisco, California, United States
Wellstar Research Institute
Marietta, Georgia, United States
Baylor College of Medicine
Houston, Texas, United States
University of Wisconsin School of Medicine & Public Health
Madison, Wisconsin, United States