Active — Not RecruitingNot Applicable

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

United States600 participantsStarted 2025-02-07

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time-to-result (TTR) of hs-cTnI

Timeframe: Index visit to Hour 24

Trial details

NCT IDNCT06899776

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-09-15

View on ClinicalTrials.gov More ACS (Acute Coronary Syndrome) trials