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

NCT06899776 | Active Not Recruiting DMC FDA Device

• 1 other identifier: IRB00117677
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

ACS (Acute Coronary Syndrome)

Keywords

chest pain; myocardial infarction; Emergency Department

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Time-to-last-troponin-result (TTLT)

  Index visit to Hour 24

• Time-to-disposition decision (TTD)

  Index visit to Hour 24

• ED length of stay (LOS)

  Index visit to Hour 72

• ED Revenue amount

  Index visit to Month 6

• Time-to-treatment (TTT)

  Index visit to Hour 24

Study Arms (1)

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

Interventions

Abbott i-STAT point of care (POC) device 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.

Patients with possible ACS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Abbott Point of Care: collaborator

Study Sites (3)

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

High Point Medical Center

High Point, North Carolina, 27262, United States

Location

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27517, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Chest Pain; Myocardial Infarction; Emergencies

Interventions

Surgical Instruments

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis; Disease Attributes

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Officials

• Simon Mahler, MD, MS

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 28, 2025
• Study Start: February 7, 2025
• Primary Completion: September 15, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)