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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: ACS (Acute Coronary Syndrome)
• Intervention / Treatment: Device: Abbott i-STAT point of care (POC) device

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
    • High Point, North Carolina, United States, 27262
      • High Point Medical Center
    • Winston-Salem, North Carolina, United States, 27517
      • Wake Forest School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults (≥18 years old) presenting to the ED with symptoms concerning for acute coronary syndrome (ACS) and an ECG and troponin ordered as part of standard of care, will be eligible for accrual. Patients with STEMI activation or unstable vital signs will be excluded. In addition, patients will be required to have a (extra) lithium heparin blood sample collected within ± 5 minutes of their clinical draw for hs-cTnI. Patients with central laboratory hs-cTnI testing or a hs-cTnI measure resulted prior to study accrual also be excluded.

Description

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 without apparent 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 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 study accrual
• Prior enrollment
• Terminal diagnosis with life expectancy less than 6 months

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with possible ACS; Adult Emergency Department patients with symptoms suggestive of acute coronary syndrome undergoing a standard-of-care evaluation possible acute coronary syndrome (ACS) in the ED including blood testing for hs-cTnI (Beckman Coulter) completed in a core laboratory.	Device: Abbott i-STAT point of care (POC) device; 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 POC device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-to-result (TTR) of hs-cTnI	Defined as the time from blood collection to result time of the hs-cTnI assay, as recorded by research staff for the Abbott i-STAT POC device and by the electronic health record for central lab Beckman Coulter Access 2 hs-cTnI measures. TTR will be collected for each troponin test ordered and collected in the Emergency Department (typically two tests per patient).	Index visit to Hour 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-to-last-troponin-result (TTLT)	Defined as the time from ED arrival to the result time of the last hs-cTnI measure in the ED (by the POC and central lab strategies).	Index visit to Hour 24
Time-to-disposition decision (TTD)	Defined as the time from the patient being bedded in the ED to provider decision on disposition (discharge vs admission).	Index visit to Hour 24
ED length of stay (LOS)	Defined as the time from ED arrival to disposition (discharged, admitted, observation unit, left against medical advice, transfer, etc.).	Index visit to Hour 72
ED Revenue amount	Calculate the associated ED revenue generated based on an average of $550 in revenue per bed-hour.	Index visit to Month 6
Time-to-treatment (TTT)	Defined by the time from the patient being bedded in the ED to the provider's decision to initiate treatment for patients with a Type 1 Non-ST-Segment Elevation Myocardial Infarction (NSTEMI) diagnosis (e.g., heparin drip).	Index visit to Hour 24
Number of Myocardial Infarctions (MI)	Number of Myocardial Infarctions (MI)	Baseline and Week 1
Number of Cardiac Deaths	Number of Cardiac Deaths	Baseline and Day 30

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Abbott Point of Care
• Investigators: Principal Investigator: Simon Mahler, MD, MS, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2025
• Primary Completion (Actual): September 15, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: March 5, 2025
• First Submitted That Met QC Criteria: March 26, 2025
• First Posted (Actual): March 28, 2025

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: chest pain; Emergency Department; myocardial infarction
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Disease Attributes; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergencies; Myocardial Infarction; Acute Coronary Syndrome; Chest Pain; Surgical Equipment; Equipment and Supplies; Surgical Instruments
• Other Study ID Numbers: IRB00117677

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No