Status:
ACTIVE_NOT_RECRUITING
Assessing Chest Pain Using Point-of-Care High-Sensitivity Troponin I in the Emergency Department
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
Abbott Point of Care
Conditions:
ACS (Acute Coronary Syndrome)
Eligibility:
All Genders
18+ years
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 7 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06899776
Start Date
February 7 2025
End Date
July 1 2026
Last Update
December 11 2025
Active Locations (3)
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1
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
2
High Point Medical Center
High Point, North Carolina, United States, 27262
3
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27517