Assessing Chest Pain Using Point-of-Care High-Sensitivity Troponin I in the Emergency Department

Last updated: March 26, 2025
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Coronary Artery Disease

Cardiac Disease

Treatment

Abbott i-STAT point of care (POC) device

Clinical Study ID

NCT06899776
IRB00117677
  • Ages > 18
  • All Genders

Study Summary

The goal of this proposal is to improve the quality and value of care for patients with acute chest pain by investigating the potential impact of point-of-care (POC) high sensitivity cardiac troponin (hs-cTn) testing in the Emergency Department (ED) and exploring how best to integrate POC hs-cTnl into ED risk stratification workflows. The study hypothesizes that the Abbott i-STAT POC hs-cTnI assay will decrease time-to-result (TTR) and ED length of stay (LOS), while increasing ED revenue for patients with acute chest pain compared to a strategy of central laboratory hs-cTnI testing.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age greater than or equal to18 years

  • Symptoms suggestive of acute coronary syndrome:

  • Acute chest, epigastric, neck, jaw or arm pain or discomfort or pressure withoutapparent non-cardiac source

  • Shortness of breath, nausea, vomiting, fatigue/malaise, or

  • Other equivalent discomfort suggestive of an myocardial infarction (MI)

  • Electrocardiogram (ECG) ordered as part of standard of care

  • At least one troponin collected as standard of care

  • Study specific blood sample collected within ± 5 minutes of clinical draw

Exclusion

Exclusion Criteria:

  • ST-segment elevation myocardial infarction (STEMI) Activation

  • Unstable vitals signs: symptomatic hypotension at the time of enrollment (systolic < 90 mm Hg), tachycardia (HR>120), bradycardia (HR<40), and hypoxemia (<90%pulse-oximetry on room air or normal home oxygen flow rate)

  • Central laboratory hs-cTn testing resulted or in process (>5 minutes) prior to studyaccrual

  • Prior enrollment

  • Terminal diagnosis with life expectancy less than 6 months

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: Abbott i-STAT point of care (POC) device
Phase:
Study Start date:
February 07, 2025
Estimated Completion Date:
February 01, 2026

Study Description

Use of point-of-care (POC) testing in the Emergency Department (ED) has been previously established as a method to reduce the time-to-disposition-decision (TTD) making for emergency physicians, which in-turn can reduce ED length of stay (LOS) and time-to-treatment (TTT) of time sensitive conditions, such as myocardial infarctions (MIs). Recently, new POC high sensitivity cardiac troponin I (hs-cTnI) assays have been developed which offer similar diagnostic performance to traditional central lab hs-cTnI testing. However, data examining POC hs-cTnI measurement in U.S. ED settings are limited. In particular, studies have yet to evaluate the potential impact of POC hs-cTnI implementation on time to troponin result (TTR), time-to-last-troponin-result (TTLT), time-to-disposition-decision (TTD), time-to-treatment (TTT), and ED LOS. In addition, limited data exists on how best to implement POC hs-cTnI into ED clinical practice, such as whether POC hs-cTnI measures should be paired with a risk score or incorporated into an accelerated diagnostic protocol.

This record is a prospective multisite observational cohort study of 600 adult ED patients with symptoms suggestive of acute coronary syndrome and without ST-segment elevation myocardial infarction (STEMI) across 3 EDs. Participants, accrued under a waiver of informed consent, will undergo a standard-of-care evaluation for possible acute coronary syndrome (ACS) in the ED including blood testing for hs-cTnI (Beckman Coulter) completed in a central laboratory. During the study period all ED patients with chest pain will have an extra lithium heparin blood sample obtained for each troponin test ordered and collected in the ED (typically 2, but this may range from 1-3 troponin measures), which will be used for immediate hs-cTnI measurement by research personnel using an Abbott i-STAT Alinity. Clinicians will be blinded to the POC hs-cTnI results and will base clinical decisions on central laboratory hs-cTn measures. Blood draw times, result times for point-of-care (POC) and central laboratory measures, patient ED arrival, patient ED bedded, ED disposition decision times, and ED discharge times will be recorded on all patients. Following each POC hs-cTnI measurement the treating attending physician will be surveyed regarding whether a negative or positive POC result would change ED disposition or treatment including time stamps to determine estimated TTD, ED LOS and TTT for the POC hs-cTnI measurement strategy. Data from these surveys will be compared to actual TTD, ED LOS and treatment times based on the central laboratory hs-cTnI measurement strategy.

Connect with a study center

  • Carolinas Medical Center

    Charlotte, North Carolina 28203
    United States

    Active - Recruiting

  • High Point Medical Center

    High Point, North Carolina 27262
    United States

    Active - Recruiting

  • Wake Forest School of Medicine

    Winston-Salem, North Carolina 27517
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.