Clinical trialNCT07464704SuspendedObservational

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

SponsorRemote Cardiac EnablementEnrollment350High Grade Obstructive NSTE-ACS

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Sanjeev Bhavnani, MD
Remote Cardiac Enablement
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

6 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Uc San Diego Health - Sulpizio Cardiovascular Center/actri 2w502-A10
La Jolla, California, United States
Ucsf - Parnassas
San Francisco, California, United States
University of California, San Francisco
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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Dec 2025
Primary completion: 31 Jul 2026
Completion: 31 Jul 2026
Last update posted: 1 Jul 2026
Registered enrollment: 350
Registry id: NCT07464704

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.