Infrasensor for Early Detection of a High-grade Obstructive NSTE-ACS
Purpose
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).
Condition
- High Grade Obstructive NSTE-ACS
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Signed Informed Consent - Age: ≥18 years - Symptomatic patients undergoing evaluation for suspected acute coronary syndrome, defined as symptoms lasting >20 minutes, and who present to a healthcare facility within 24 hours after symptom onset. - Included study subjects are those with HEART risk score > 4, and for whom CT angiography or invasive coronary angiography is intended. - The Infrasensor should only be used in 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
- Inclusion criteria: Signed Informed Consent Age: ≥18 years Symptomatic patients undergoing evaluation for suspected acute coronary syndrome, defined as symptoms lasting >20 minutes, and who present to a healthcare facility within 24 hours after symptom onset. Included study subjects are those with HEART risk score > 4, and for whom CT angiography or invasive coronary angiography is intended. The Infrasensor should only be used in 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 - Patients triaged directly with STEMI or for cardiac reasons other than suspected AMI requiring immediate medical intervention (aortic dissection, unstable cardiac arrhythmias, left bundle branch blocks) - Patients in whom an obvious alternative diagnosis is suspected at the time of arrival to hospital and without suspicion of ACS (ischemic cardiomyopathy, pulmonary hypertension, chronic total occlusion) - 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 with unstable angina, hospitalization for acute coronary syndrome, or hemodynamic instability (e.g., cardiogenic shock, malignant arrhythmias) within the past 30 days - Patients with planned coronary revascularization procedures (PCI or CABG) during the study period - Hemodynamically unstable patients as defined by institution's protocol - Exsanguination patients - Trauma patients
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross-Sectional
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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) |
Recruiting Locations
San Francisco, California 94110
Houston, Texas 77030
More Details
- Status
- Recruiting
- Sponsor
- Remote Cardiac Enablement