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| ID | Type | Description | Link |
|---|---|---|---|
| OCR15652 | Other Identifier | University of Florida | |
| 20162880 | Other Identifier | WIRB |
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| Name | Class |
|---|---|
| Roche Diagnostics GmbH | INDUSTRY |
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This is a prospective observational cohort study of ED patients with acute chest pain or other symptoms suggestive of ACS. Blood samples will be collected from study participants for High-Sensitivity Cardiac Troponin T (hs-cTnT) analysis. Results from hs-cTnT will be used for research purposes only.
Providers will be blinded to results and participants will be treated by their healthcare providers per the standard of care. Participants will have 30 and 90 day phone follow-ups to ascertain study outcomes.
Approximately 8 million - 10 million patients complaining of chest pain present to an Emergency Department (ED) annually in the United States. To avoid missing the diagnosis of acute coronary syndrome (ACS), physicians use a liberal testing strategy. Thus, >50% of ED patients with acute chest pain are hospitalized for a comprehensive cardiac evaluation (serial cardiac biomarkers and stress testing or angiography). However, <10% of these patients are ultimately diagnosed with ACS, and this pervasive over-triage costs an estimated $10 billion - $13 billion annually. Current care patterns for acute chest pain fail to focus health system resources, such as hospitalization and stress testing, on patients most likely to benefit.
It has demonstrated that an accelerated diagnostic protocol (ADP), called the HEART Pathway, which utilizes a clinical decision aid (the HEART score) and serial Cardiac Troponin (cTn) measures are sensitive for ACS (>99%) and can substantially reduce hospitalizations, stress testing, and cost compared to usual care. The HEART Pathway uses contemporary serial cTn measurements at 0 and 3 hours to exclude index myocardial infarction (MI) and relies on clinical features (history, ECG, age, and risk factors) to identify patients likely to have downstream events. However, the HEART Pathway has limitations: a) It identifies only 20 - 40% of patients for early discharge and b) it was developed before high-sensitivity cTn assays became available. Able to detect MI earlier and with greater accuracy than contemporary assays, hs-cTn assays have the potential to be integrated into decision aids to improve chest pain risk stratification. In the near future, hs-cTn assays will replace contemporary assays in the United States.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ED Patients with Acute Chest Pain | Emergency Department (ED) Patients with Acute Chest Pain will have blood samples collected for High sensitivity cardiac troponin T (hs-CTnT) analysis. Results from this analysis will be integrated into the HEART Score/Pathway. It will later be seen if integration of the hs-cTnT outperforms the use of HEART Score/Pathway alone. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Sample | Procedure | Blood samples will be collected from study participants for hs-cTnT analysis. Results of hs-cTnT will be used for research purposes only. Providers and participants will be blinded to results and participants will be treated by their healthcare providers per the standard of care. |
| Measure | Description | Time Frame |
|---|---|---|
| High Sensitivity Cardiac Troponin T using lithium heparin tubes | The research team will obtain two lithium heparin tubes at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results. | Baseline |
| High Sensitivity Cardiac Troponin T using lithium heparin tubes | The research team will obtain two lithium heparin tubes at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results. | 1 hour after baseline |
| High Sensitivity Cardiac Troponin T using lithium heparin tubes | The research team will obtain two lithium heparin tubes at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results. | 2 hours after baseline |
| High Sensitivity Cardiac Troponin T using lithium heparin tubes | The research team will obtain two lithium heparin tubes at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results. | 3 hours after baseline |
| High Sensitivity Cardiac Troponin T using EDTA tubes | The research team will obtain one EDTA tube at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results. | Baseline |
| High Sensitivity Cardiac Troponin T using EDTA tubes |
| Measure | Description | Time Frame |
|---|---|---|
| HEART Score Calculation | By assigning zero, one, or two points - towards an atypical patient history, ECG anomalies, the patient's age, any risk factors present, and elevated Troponin - patients score on a scale of 0-10. 0-3 = Low-risk, 4 or greater = High-risk | Change from Baseline, 1, 2, 3 hours. 30 days and 90 days post discharge |
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Inclusion Criteria:
Exclusion Criteria:
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All patients 21 years of age or older with possible Acute Coronary Syndrome (ACS) and associated chest pain.
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| Name | Affiliation | Role |
|---|---|---|
| Brandon R Allen, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis | Sacramento | California | 95817 | United States | ||
| University of Florida |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39781769 | Derived | Ashburn NP, Snavely AC, Supples MW, Millard MJ, Allen BR, Christenson RH, Madsen T, Mumma BE, Hashemian T, Wilkerson RG, Mahler SA. Performance of the High-STEACS Early Rule Out Pathway Using hs-cTnT at 30 Days in a Multisite US Cohort. Circ Cardiovasc Qual Outcomes. 2025 Feb;18(2):e011084. doi: 10.1161/CIRCOUTCOMES.124.011084. Epub 2025 Jan 9. | |
| 39729682 |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D002637 | Chest Pain |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| HEART Score | Behavioral | The HEART Score is a prospectively studied scoring system to help emergency departments risk-stratify chest pain patients. Patients score on a scale of 0-10. |
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The research team will obtain one EDTA tube at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results. |
| 1 hour after baseline |
| High Sensitivity Cardiac Troponin T using EDTA tubes | The research team will obtain one EDTA tube at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results. | 2 hours after baseline |
| High Sensitivity Cardiac Troponin T using EDTA tubes | The research team will obtain one EDTA tube at baseline, 1, 2, and 3 hours for sampling and preparation for shipping to the core laboratory in Maryland for hs-cTnT processing. Providers will be blinded to hs-cTnT results. | 3 hours after baseline |
| Cardiac Troponin T (cTn) | Site-specific cTn will be measured at baseline | Baseline |
| Cardiac Troponin T (cTn) | Site-specific cTn will be measured at 3 hours unless baseline site-specific cTn tests positive | 3 hours |
| Occurrence of major adverse cardiac events (MACE) | 30 days |
| Occurrence of major adverse cardiac events (MACE) | 90 days |
| Incidence and Intensity of Adverse Events |
Number of Participants with treatment related Adverse Events as Assessed by CTCAE v4.0 |
| Change from Baseline, 1, 2, 3 hours. 30 days and 90 days post discharge |
| Gainesville |
| Florida |
| 32610 |
| United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Wake Forest University | Winston-Salem | North Carolina | 27109 | United States |
| University of Utah | Salt Lake City | Utah | 84112 | United States |
| Supples MW, Dameron AG, Powell S, Snavely AC, Ashburn NP, Allen BR, Christenson RH, Wilkerson RG, Mumma BE, Madsen TE, Mahler SA. The HET (history, electrocardiogram, and troponin) score has low efficacy and negative predictive value in a multisite U.S. cohort study. Am J Emerg Med. 2025 Mar;89:151-158. doi: 10.1016/j.ajem.2024.12.012. Epub 2024 Dec 15. |
| 38471727 | Derived | Millard MJ, Ashburn NP, Snavely AC, Hashemian T, Supples M, Allen B, Christenson R, Madsen T, McCord J, Mumma B, Stopyra J, Wilkerson RG, Mahler SA. European Society of Cardiology 0/1-hour algorithm (high-sensitivity cardiac troponin T) performance across distinct age groups. Heart. 2024 May 23;110(12):838-845. doi: 10.1136/heartjnl-2023-323621. |
| 38417221 | Derived | Ashburn NP, Snavely AC, Allen BR, Christenson RH, Madsen T, McCord JK, Mumma BE, Hashemian T, Stopyra JP, Wilkerson RG, Mahler SA. Performance of the European Society of Cardiology 0/1-hour algorithm with high-sensitivity cardiac troponin T at 90 days among patients with known coronary artery disease. Am J Emerg Med. 2024 May;79:111-115. doi: 10.1016/j.ajem.2024.02.029. Epub 2024 Feb 23. |
| 38088463 | Derived | Supples MW, Snavely AC, O'Neill JC, Ashburn NP, Allen BR, Christenson RH, Nowak R, Wilkerson RG, Mumma BE, Madsen T, Stopyra JP, Mahler SA. Sex and race differences in the performance of the European Society of Cardiology 0/1-h algorithm with high-sensitivity troponin T. Clin Cardiol. 2024 Feb;47(2):e24199. doi: 10.1002/clc.24199. Epub 2023 Dec 13. |
| 37306075 | Derived | Popp LM, Ashburn NP, Snavely AC, Allen BR, Christenson RH, Madsen T, Mumma BE, Nowak R, Stopyra JP, Wilkerson RG, Mahler SA. Race differences in cardiac testing rates for patients with chest pain in a multisite cohort. Acad Emerg Med. 2023 Oct;30(10):1020-1028. doi: 10.1111/acem.14762. Epub 2023 Jun 19. |
| 37131096 | Derived | Neumann JT, Twerenbold R, Ojeda F, Aldous SJ, Allen BR, Apple FS, Babel H, Christenson RH, Cullen L, Di Carluccio E, Doudesis D, Ekelund U, Giannitsis E, Greenslade J, Inoue K, Jernberg T, Kavsak P, Keller T, Lee KK, Lindahl B, Lorenz T, Mahler SA, Mills NL, Mokhtari A, Parsonage W, Pickering JW, Pemberton CJ, Reich C, Richards AM, Sandoval Y, Than MP, Toprak B, Troughton RW, Worster A, Zeller T, Ziegler A, Blankenberg S; ARTEMIS study group. Personalized diagnosis in suspected myocardial infarction. Clin Res Cardiol. 2023 Sep;112(9):1288-1301. doi: 10.1007/s00392-023-02206-3. Epub 2023 May 2. |
| 33474976 | Derived | Allen BR, Christenson RH, Cohen SA, Nowak R, Wilkerson RG, Mumma B, Madsen T, McCord J, Huis In't Veld M, Massoomi M, Stopyra JP, Montero C, Weaver MT, Yang K, Mahler SA. Diagnostic Performance of High-Sensitivity Cardiac Troponin T Strategies and Clinical Variables in a Multisite US Cohort. Circulation. 2021 Apr 27;143(17):1659-1672. doi: 10.1161/CIRCULATIONAHA.120.049298. Epub 2021 Jan 21. |
| D010146 |
| Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |