Using point-of-care high-sensitivity troponin testing for chest pain in the emergency department
Assessing Chest Pain Using Point-of-Care High-Sensitivity Troponin I in the Emergency Department
This study is testing if a quick blood test for heart damage can help doctors treat patients with chest pain in the emergency room faster and more effectively.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 3 sites (Charlotte, North Carolina and 2 other locations) |
| Trial ID | NCT06899776 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enhance care for patients experiencing acute chest pain by evaluating the effectiveness of point-of-care (POC) high-sensitivity cardiac troponin I (hs-cTnI) testing in emergency departments. It will assess how integrating POC hs-cTnI testing can improve time-to-result, reduce emergency department length of stay, and optimize risk stratification workflows. The study will involve 600 adult patients with symptoms suggestive of acute coronary syndrome across three emergency departments, utilizing the Abbott i-STAT POC device for testing. Participants will undergo standard evaluations for acute coronary syndrome while their results are compared to traditional central laboratory testing methods.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older presenting with symptoms suggestive of acute coronary syndrome.
Not a fit: Patients experiencing ST-segment elevation myocardial infarction (STEMI) or those with unstable vital signs may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the time patients spend in the emergency department while improving the accuracy of acute coronary syndrome diagnoses.
How similar studies have performed: Previous studies have shown promise in using point-of-care testing for similar conditions, but this specific implementation in U.S. emergency departments is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Charlotte, North Carolina and 2 other locations
- Carolinas Medical Center — Charlotte, North Carolina, United States (Recruiting)
- High Point Medical Center — High Point, North Carolina, United States (Recruiting)
- Wake Forest School of Medicine — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Simon Mahler, MD, MS — Wake Forest University Health Sciences
- Study coordinator: Lauren Koehler
- Email: lekoehle@wakehealth.edu
- Phone: 3367164646
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.