High-Sensitivity Cardiac Troponin T to OPtimize Chest Pain Risk Stratification
NCT ID: NCT02984436
Last Updated: 2020-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1572 participants
OBSERVATIONAL
2017-01-25
2020-09-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Blood Sample
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.
HEART Score
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.
Interventions
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Blood Sample
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.
HEART Score
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Chest discomfort or other symptoms consistent with possible ACS in which the treating physician plans to obtain an ECG and cTn for the patient's evaluation in the ED
Exclusion Criteria
2. Evidence of shock identified by the provider at the bedside and/or the PI
3. Terminal diagnosis with life expectancy less than 90 days
4. A non-cardiac medical, surgical, or psychiatric illness determined by the provider to require admission
5. Prior enrollment in the STOP CP study
6. Lack of capacity to provide consent and comply with study procedures
7. Inability to be reliably reached after the index visit for follow-up
8. Non-English speaking
9. Pregnant patients
10. Provider does not intend on obtaining serial cTn assays for evaluation of ACS
11. The first study draw (T0) will exceed 1 hour after the site-specific standard of care troponin draw
12. Unable or unwilling to authorize medical records release
21 Years
ALL
No
Sponsors
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Roche Diagnostics GmbH
INDUSTRY
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Brandon R Allen, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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UC Davis
Sacramento, California, United States
University of Florida
Gainesville, Florida, United States
University of Maryland
Baltimore, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
Wake Forest University
Winston-Salem, North Carolina, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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OCR15652
Identifier Type: OTHER
Identifier Source: secondary_id
20162880
Identifier Type: OTHER
Identifier Source: secondary_id
STOP CP
Identifier Type: -
Identifier Source: org_study_id