High Grade Obstructive NSTE-ACSNCT07464704
Infrasensor for Early Detection of a High-grade Obstructive NSTE-ACS
An observational study of High Grade Obstructive NSTE-ACS, run by Remote Cardiac Enablement at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Grade Obstructive NSTE-ACS
- How many people
- 350 participants
- Where
- 6 sitesUnited States
- Study dates
- 30 Dec 2025to Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- Hemodynamically unstable patients as defined by institutions protocol
- Trauma patients
- Patients with acute hemorrhage patients
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Baylor College of Medicine
Houston, Texas, 77030
UC San Diego Health - Sulpizio Cardiovascular Center/ACTRI 2W502-A10
La Jolla, California, 92037
University of Wisconsin School of Medicine & Public Health
Madison, Wisconsin, 53705
Wellstar Research Institute
Marietta, Georgia, 30060
University of California, San Francisco
San Francisco, California, 94110
UCSF - Parnassas
San Francisco, California, 94143
About this study
Official title: 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).
- Conditions
- High Grade Obstructive NSTE-ACS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (ED presentation) through hospital discharge, up to 30 days
Secondary outcomes (1)
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.
Measured: Baseline (ED presentation) through hospital discharge, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start30 Dec 2025
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Why it stopped: Study enrollment and interventions are temporarily paused due to lack of operational funding. This is not an IRB suspension.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Grade Obstructive NSTE-ACSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Remote Cardiac Enablement
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sanjeev Bhavnani, MD, Principal investigator, Remote Cardiac Enablement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464704
- Sponsor's protocol ID
- RCE_MS_005
- Status last verified
- Mar 2026
- First submitted
- 17 Dec 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infrasensor for Early Identification of High-grade Obstructive Non-ST-segment Elevation Acute Coronary Syndrome in Patients With Suspected Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT07464704
- Acronym / sponsor ID
- RCE_MS_005
- Conditions
- High Grade Obstructive NSTE-ACS
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Study enrollment and interventions are temporarily paused due to lack of operational funding. This is not an IRB suspension.
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Remote Cardiac EnablementIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic performance of the Infrasensor for detection of high-grade obstructive NSTE-ACS
Time frame: Baseline (ED presentation) through hospital discharge, up to 30 days
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.
1 secondary outcome
Additional diagnostic performance metrics of the Infrasensor
Time frame: Baseline (ED presentation) through hospital discharge, up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjeev Bhavnani, MD principal investigator
Remote Cardiac Enablement
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Grade Obstructive NSTE-ACS, run by Remote Cardiac Enablement at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of the Infrasensor for detection of high-grade obstructive NSTE-ACS (time frame: Baseline (ED presentation) through hospital discharge, up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.