ACS (Acute Coronary Syndrome)ACUTENCT06899776
Assessing Chest Pain Using Point-of-Care High-Sensitivity Troponin I in the Emergency Department
An observational study of ACS (Acute Coronary Syndrome), run by Wake Forest University Health Sciences at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ACS (Acute Coronary Syndrome)
- What is being tested?
- Abbott i-STAT point of care (POC) device
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Feb 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Carolinas Medical Center
Charlotte, North Carolina, 28203
High Point Medical Center
High Point, North Carolina, 27262
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27517
About this study
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.
Read the 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.
- Conditions
- ACS (Acute Coronary Syndrome)
- Being tested
- Abbott i-STAT point of care (POC) device
- Keywords
- chest pain, myocardial infarction, Emergency Department
- Medical subject headings
- Acute Coronary Syndrome, Chest Pain, Myocardial Infarction, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abbott i-STAT point of care (POC) deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Abbott i-STAT point of care (POC) device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Index visit to Hour 24
Secondary outcomes (7)
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).
Measured: 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).
Measured: 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.).
Measured: 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.
Measured: 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).
Measured: Index visit to Hour 24
Number of Myocardial Infarctions (MI)
Number of Myocardial Infarctions (MI)
Measured: Baseline and Week 1
Number of Cardiac Deaths
Number of Cardiac Deaths
Measured: Baseline and Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start7 Feb 2025
- Primary completion15 Sep 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ACS (Acute Coronary Syndrome)Studies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Point of Care
- Responsible party
- Sponsor
- Investigators
- Simon Mahler, MD, MS, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899776
- Sponsor's protocol ID
- IRB00117677
- Acronym
- ACUTE
- Status last verified
- Jan 2026
- First submitted
- 5 Mar 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Mahler SA, Ashburn NP, Villenthi A, Pearson DA, Pugh HD, Hutchison BT, Supples MW, Snavely AC. Can point-of-care high sensitivity troponin improve efficiency: a multisite US study. Am J Emerg Med. 2026 Aug 19;110:167-172. doi: 10.1016/j.ajem.2026.08.035. Online ahead of print.
PubMed 42641508Mahler SA, Ashburn NP, Villenthi A, Pearson DA, Pugh HD, Hutchison BT, Supples MW, Snavely AC. Validation of a 0/2-Hour Point-Of-Care High Sensitivity Troponin Algorithm: A Multisite US Study. Acad Emerg Med. 2026 Jul;33(7):e70379. doi: 10.1111/acem.70379.
PubMed 42470147
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Chest Pain Using Point-of-Care High-Sensitivity Troponin I in the Emergency Department
- ClinicalTrials.gov ID
- NCT06899776
- Acronym / sponsor ID
- ACUTE / IRB00117677
- Conditions
- ACS (Acute Coronary Syndrome)
- Keywords
- chest pain, myocardial infarction, Emergency Department
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Abbott Point of Care
- Study start
- 7 Feb 2025 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with possible ACS | – | Device: Abbott i-STAT point of care (POC) deviceAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abbott i-STAT point of care (POC) deviceDuring 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. | Device | Patients with possible ACS |
Primary outcome
Time-to-result (TTR) of hs-cTnI
Time frame: Index visit to Hour 24
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).
7 secondary outcomes
Time-to-last-troponin-result (TTLT)
Time frame: Index visit to Hour 24
Time-to-disposition decision (TTD)
Time frame: Index visit to Hour 24
ED length of stay (LOS)
Time frame: Index visit to Hour 72
ED Revenue amount
Time frame: Index visit to Month 6
Time-to-treatment (TTT)
Time frame: Index visit to Hour 24
Number of Myocardial Infarctions (MI)
Time frame: Baseline and Week 1
Number of Cardiac Deaths
Time frame: Baseline and Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Derived from this study: PubMed 42641508Mahler SA, Ashburn NP, Villenthi A, Pearson DA, Pugh HD, Hutchison BT, Supples MW, Snavely AC. Can point-of-care high sensitivity troponin improve efficiency: a multisite US study. Am J Emerg Med. 2026 Aug 19;110:167-172. doi: 10.1016/j.ajem.2026.08.035. Online ahead of print.
- Derived from this study: PubMed 42470147Mahler SA, Ashburn NP, Villenthi A, Pearson DA, Pugh HD, Hutchison BT, Supples MW, Snavely AC. Validation of a 0/2-Hour Point-Of-Care High Sensitivity Troponin Algorithm: A Multisite US Study. Acad Emerg Med. 2026 Jul;33(7):e70379. doi: 10.1111/acem.70379.
- Individual participant dataSharing planned: No
Related trials for ACS (Acute Coronary Syndrome)
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Not yet recruitingPhase 3
Aspirin for the Prevention of Ischemic Complications in Giant Cell Arteritis
Giant Cell Arteritis (GCA), Acute Coronary Syndrome (ACS)
Not yet recruitingObservational study
Prognostic Value of Functional-Nutritional Status in Older Adults With Acute Coronary Syndrome
Acute Coronary Syndromes (ACS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Mahler, MD, MS principal investigator
Wake Forest University Health Sciences
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ACS (Acute Coronary Syndrome), run by Wake Forest University Health Sciences at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-to-result (TTR) of hs-cTnI (time frame: Index visit to Hour 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06899776, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.