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NCT07464704 · ClinicalTrials.gov registry record
Infrasensor for Early Detection of a High-grade Obstructive NSTE-ACS
A clinical trial of High Grade Obstructive NSTE-ACS, sponsored by Remote Cardiac Enablement.
- Recruiting
- Registry status
- 350
- Enrollment target
- 2
- Study locations
NCT07464704: Recruiting study of High Grade Obstructive NSTE-ACS, sponsored by Remote Cardiac Enablement.
NCT07464704 is a study of High Grade Obstructive NSTE-ACS that is actively recruiting participants, run by Remote Cardiac Enablement. The registered enrollment target is 350 participants. The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07464704, a study of High Grade Obstructive NSTE-ACS, is actively recruiting participants, sponsored by Remote Cardiac Enablement.
- RECRUITING
- Registry status
- 350 participants
- Enrollment target
- 2
- Study locations
Study 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. 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 Studied
Study Locations (2)
California
- University of California, San Francisco - San Francisco
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2025-12-30 |
| Est. Completion | 2026-07 |
What NCT07464704 shows while recruiting
NCT07464704 is an observational study that tracks outcomes without assigning an intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with High Grade Obstructive NSTE-ACS appearing as the primary indexed condition, and to 0 interventions.
NCT07464704 reports a single indexed study location in California, Texas.
Frequently Asked Questions
What is clinical trial NCT07464704 about?
NCT07464704 is a clinical study titled "Infrasensor for Early Detection of a High-grade Obstructive NSTE-ACS". 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 ar...
What is the current status of trial NCT07464704?
This trial is currently recruiting. The enrollment target is 350 participants. The study started on 2025-12-30. Estimated completion is 2026-07.
What conditions does trial NCT07464704 study?
This clinical trial studies the following conditions: High Grade Obstructive NSTE-ACS.
Who is sponsoring clinical trial NCT07464704?
This trial is sponsored by Remote Cardiac Enablement, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07464704 being conducted?
This trial has 2 study locations across California, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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