Infrasensor to detect high-grade obstructive NSTE-ACS early
Infrasensor for Early Identification of High-grade Obstructive Non-ST-segment Elevation Acute Coronary Syndrome in Patients With Suspected Acute Coronary Syndrome
This test will see if the Infrasensor can quickly detect high-grade obstructive NSTE-ACS in adults who come to the emergency department with possible heart attack symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Remote Cardiac Enablement Industry-sponsored |
| Locations | 6 sites (La Jolla, California and 5 other locations) |
| Trial ID | NCT07464704 on ClinicalTrials.gov |
What this trial studies
This is a prospective, cross-sectional, multicenter pivotal study to validate the Infrasensor's performance for detecting high-grade obstructive NSTE-ACS. Adults presenting within 24 hours to participating emergency or acute care settings with symptoms suggestive of acute coronary syndrome who are planned for invasive coronary angiography will have a five-minute Infrasensor measurement on the arm. Device results will be compared to angiographic diagnosis of high-grade obstructive coronary artery disease (left main >50% or ≥70% stenosis in any major coronary artery or emergent revascularization) to calculate sensitivity, specificity, predictive values, and overall accuracy. Patients triaged directly for STEMI, those with skin lesions or arm equipment that interfere with the device, or who cannot remain still for the measurement are excluded.
Who should consider this trial
Good fit: Adults aged 18 or older presenting within 24 hours with symptoms suggestive of ACS who are planned for invasive coronary angiography and can remain still for a five-minute arm measurement with intact skin are ideal candidates.
Not a fit: Patients triaged directly for immediate STEMI care, those with scars or open wounds at the measurement site, unstable cardiac conditions requiring immediate intervention, or who cannot keep the device arm still are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the Infrasensor could provide a rapid, noninvasive way to identify patients with severe obstructive coronary disease and help prioritize timely care and revascularization.
How similar studies have performed: The general concept of noninvasive sensors for ischemia is emerging, but there is limited prior evidence specifically validating this Infrasensor against coronary angiography.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
La Jolla, California and 5 other locations
- UC San Diego Health - Sulpizio Cardiovascular Center/ACTRI 2W502-A10 — La Jolla, California, United States (Recruiting)
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
- UCSF - Parnassas — San Francisco, California, United States (Recruiting)
- Wellstar Research Institute — Marietta, Georgia, United States (Recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
- University of Wisconsin School of Medicine & Public Health — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Sanjeev Bhavnani, MD — Remote Cardiac Enablement
- Study coordinator: Atandra CEO
- Email: atandra@rce.ai
- Phone: 408-796-9709
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.