Actively Recruiting
Infrasensor for Early Detection of a High-grade Obstructive NSTE-ACS
Led by Remote Cardiac Enablement · Updated on 2026-03-27
350
Participants Needed
6
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Infrasensor for Early Detection of a High-grade Obstructive NSTE-ACS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to sign informed consent
- Age 18 years or older
- Symptoms suggestive of acute coronary syndrome within 24 hours of emergency or acute care presentation
- Intended to undergo invasive coronary angiography
- Alert and able to keep still for 5-minute Infrasensor measurement
- Clean, intact skin at the measurement site without blood pressure cuffs or IV lines on the arm used
You will not qualify if you...
- Scars, open wounds, or lesions interfering with Infrasensor placement
- Triaged directly with STEMI or cardiac emergencies other than suspected AMI needing immediate intervention
- Clear alternative diagnosis without suspicion of acute coronary syndrome
- Recent heart attack, coronary stent, or bypass surgery within past 30 days
- Hemodynamic instability including cardiogenic shock or unstable arrhythmias
- Planned coronary revascularization during the study period
- Trauma patients
- Patients with acute hemorrhage
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
UC San Diego Health - Sulpizio Cardiovascular Center/ACTRI 2W502-A10
La Jolla, California, United States, 92037
Actively Recruiting
2
University of California, San Francisco
San Francisco, California, United States, 94110
Actively Recruiting
3
UCSF - Parnassas
San Francisco, California, United States, 94143
Actively Recruiting
4
Wellstar Research Institute
Marietta, Georgia, United States, 30060
Actively Recruiting
5
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
6
University of Wisconsin School of Medicine & Public Health
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
A
Atandra CEO
CONTACT
J
Jessie Katz
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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