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RECRUITING
NCT07464704

Infrasensor for Early Detection of a High-grade Obstructive NSTE-ACS

Sponsor: Remote Cardiac Enablement

View on ClinicalTrials.gov

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

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