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

Infrasensor for Early Identification of High-grade Obstructive Non-ST-segment Elevation Acute Coronary Syndrome in Patients With Suspected Acute Coronary Syndrome

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 Overview

• Status: Recruiting
• Conditions: High Grade Obstructive NSTE-ACS

• Study Type: Observational
• Enrollment (Estimated): 350

Contacts and Locations

• Study Contact: Name: Atandra CEO; Phone Number: 408-796-9709; Email: atandra@rce.ai
• Study Contact Backup: Name: Jessie Katz; Phone Number: 917-359-3178; Email: jessie@rce.ai

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Recruiting
      • UC San Diego Health - Sulpizio Cardiovascular Center/ACTRI 2W502-A10
      • Contact: Megan Woelkers; Email: mwwoelkers@health.ucsd.edu
      • Principal Investigator: Lori Daniels, MD
    • San Francisco, California, United States, 94110
      • Recruiting
      • University of California, San Francisco
      • Contact: Chui Ong; Email: chuimei.ong@ucsf.edu
      • Principal Investigator: Alan Wu, Ph.D
    • San Francisco, California, United States, 94143
      • Recruiting
      • UCSF - Parnassas
      • Contact: Chui Mei Ong; Email: ChuiMei.Ong@ucsf.edu
      • Principal Investigator: Alan Wu, PhD
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Recruiting
      • Wellstar Research Institute
      • Contact: Shan Fitzwater; Email: Shan.Fitzwater@wellstar.org
      • Principal Investigator: Rajnish Prasad, MD
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor College of Medicine
      • Contact: Kelly Keene, BSN; Phone Number: 713-873-9818; Email: kelly.keene@bcm.edu
      • Principal Investigator: Zubaid Rafique, MD
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • Recruiting
      • University of Wisconsin School of Medicine & Public Health
      • Contact: Lex Oliver; Email: aloliver@medicine.wisc.edu
      • Principal Investigator: Jesus Trevino, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will be consecutive enrollment up to 350 patients presenting to the Emergency Department undergoing evaluation for an acute coronary syndrome in whom invasive coronary angiogram is also intended.

Description

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 equipment on the arm used for measurement.

Exclusion criteria:

• Patients with scars, open wounds, or lesions that may interfere with the Infrasensor application
• ACS patients triaged directly with STEMI or for cardiac reasons other than suspected AMI requiring immediate medical intervention (aortic dissection, unstable cardiac arrhythmias)
• Patients in whom an obvious alternative diagnosis is suspected at the time of arrival to hospital and without suspicion of ACS (pulmonary hypertension, musculoskeletal chest pain)
• Patients with acute myocardial infarction, percutaneous coronary intervention (including coronary stent placement), and/or coronary artery bypass graft surgery within the past 30 days
• Patients being hospitalized for acute coronary syndrome including NSTEMI who have hemodynamic instability (e.g., cardiogenic shock, unstable arrhythmias)
• Patients with planned coronary revascularization procedures (PCI or CABG) during the study period including patients who were evaluated previously for NSTEMI and determined to undergo a planned cardiac catheterization on an outpatient basis at a future time point.
• Hemodynamically unstable patients as defined by institutions protocol
• Trauma patients
• Patients with acute hemorrhage patients

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
symptomatic patients undergoing a hospital-based evaluation for ACS; patients presenting to acute care settings, such as Emergency Departments (ED), with symptoms suggestive of an acute coronary syndrome (ACS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic 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.	Baseline (ED presentation) through hospital discharge, up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (ED presentation) through hospital discharge, up to 30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day major adverse cardiovascular events (MACE) in patients without angiography	Assessment of 30-day clinical outcomes (MACE) in participants who underwent Infrasensor measurement but did not receive invasive coronary angiography, to explore the association between Infrasensor results and short-term clinical outcomes.	30 days after ED presentation
Infrasensor performance by Monk Skin Tone (MST)	Subgroup analysis of Infrasensor diagnostic performance stratified by Monk Skin Tone pigmentation classifications collected for all participants.	Baseline (ED presentation) through hospital discharge, up to 30 days

Collaborators and Investigators

• Sponsor: Remote Cardiac Enablement
• Investigators: Principal Investigator: Sanjeev Bhavnani, MD, Remote Cardiac Enablement

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: December 17, 2025
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 11, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: RCE_MS_005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared. The study includes detailed clinical, procedural, and imaging data collected to support regulatory evaluation of a proprietary investigational medical device. Due to confidentiality obligations, protection of participant privacy, and the absence of a pre-specified data-sharing plan, individual participant-level data will not be made publicly available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No