Acute Coronary SyndromeSTOP CPNCT02984436
High-Sensitivity Cardiac Troponin T to OPtimize Chest Pain Risk Stratification
An observational study of Acute Coronary Syndrome and Chest Pain, run by University of Florida at 6 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Chest Pain
- What is being tested?
- Blood Sample and HEART Score
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 1,572 participants
- Where
- 6 sitesUnited States
- Study dates
- 25 Jan 2017to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients 21 years of age or older with possible Acute Coronary Syndrome (ACS) and associated chest pain.
Who may be able to join
- Age greater than or equal to 21 years at the time of enrollment in the ED
- 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
Who cannot join
- New ST-segment elevation consistent with myocardial infarction
- Evidence of shock identified by the provider at the bedside and/or the PI
- Terminal diagnosis with life expectancy less than 90 days
- A non-cardiac medical, surgical, or psychiatric illness determined by the provider to require admission
- Prior enrollment in the STOP CP study
- Lack of capacity to provide consent and comply with study procedures
Show all 12Show fewer
- Inability to be reliably reached after the index visit for follow-up
- Non-English speaking
- Pregnant patients
- Provider does not intend on obtaining serial cTn assays for evaluation of ACS
- The first study draw (T0) will exceed 1 hour after the site-specific standard of care troponin draw
- Unable or unwilling to authorize medical records release
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Maryland
Baltimore, Maryland, 21201
Henry Ford Health System
Detroit, Michigan, 48202
University of Florida
Gainesville, Florida, 32610
UC Davis
Sacramento, California, 95817
University of Utah
Salt Lake City, Utah, 84112
Wake Forest University
Winston-Salem, North Carolina, 27109
About this study
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.
Read the detailed description
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.
- Conditions
- Acute Coronary Syndrome, Chest Pain
- Being tested
- Blood Sample, HEART Score
- Medical subject headings
- Acute Coronary Syndrome, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood SampleProcedure or surgery
Also called Blood draw
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 ScoreBehavioural
Also called HEART Pathway
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Blood Sample; Behavioral: HEART Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 hours after baseline
Cardiac Troponin T (cTn)
Site-specific cTn will be measured at baseline
Measured: Baseline
Cardiac Troponin T (cTn)
Site-specific cTn will be measured at 3 hours unless baseline site-specific cTn tests positive
Measured: 3 hours
Occurrence of major adverse cardiac events (MACE)
Measured: 30 days
Occurrence of major adverse cardiac events (MACE)
Measured: 90 days
Secondary outcomes (2)
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
Measured: Change from Baseline, 1, 2, 3 hours. 30 days and 90 days post discharge
Incidence and Intensity of Adverse Events
Number of Participants with treatment related Adverse Events as Assessed by CTCAE v4.0
Measured: Change from Baseline, 1, 2, 3 hours. 30 days and 90 days post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study start25 Jan 2017
- Primary completion31 Dec 2019
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- 1,572 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Responsible party
- Sponsor
- Investigators
- Brandon R Allen, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984436
- Sponsor's protocol ID
- STOP CP
- Other IDs
- OCR15652, 20162880
- Acronym
- STOP CP
- Status last verified
- Dec 2020
- First submitted
- 1 Dec 2016
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39781769Supples 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.
PubMed 39729682Millard 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.
PubMed 38471727Ashburn 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.
PubMed 38417221Supples 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.
PubMed 38088463Popp 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.
PubMed 37306075Neumann 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.
PubMed 37131096Allen 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.
PubMed 33474976
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Sensitivity Cardiac Troponin T to OPtimize Chest Pain Risk Stratification
- ClinicalTrials.gov ID
- NCT02984436
- Acronym / sponsor ID
- STOP CP / STOP CP
- Conditions
- Acute Coronary Syndrome, Chest Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,572 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Study start
- 25 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 7 Dec 2016 (estimated)
- 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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ED Patients with Acute Chest Pain | – | Procedure: Blood Sample, Behavioral: HEART ScoreEmergency 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients 21 years of age or older with possible Acute Coronary Syndrome (ACS) and associated chest pain.
Key inclusion criteria (2 listed)
- Age greater than or equal to 21 years at the time of enrollment in the ED
- 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
Key exclusion criteria (12 listed)
- New ST-segment elevation consistent with myocardial infarction
- Evidence of shock identified by the provider at the bedside and/or the PI
- Terminal diagnosis with life expectancy less than 90 days
- A non-cardiac medical, surgical, or psychiatric illness determined by the provider to require admission
- Prior enrollment in the STOP CP study
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 |
|---|---|---|
| Blood SampleAlso: Blood drawBlood 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. | Procedure or surgery | ED Patients with Acute Chest Pain |
| HEART ScoreAlso: HEART PathwayThe 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. | Behavioural | ED Patients with Acute Chest Pain |
Primary outcome
High Sensitivity Cardiac Troponin T using lithium heparin tubes
Time frame: Baseline
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.
High Sensitivity Cardiac Troponin T using lithium heparin tubes
Time frame: 1 hour after baseline
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.
High Sensitivity Cardiac Troponin T using lithium heparin tubes
Time frame: 2 hours after baseline
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.
High Sensitivity Cardiac Troponin T using lithium heparin tubes
Time frame: 3 hours after baseline
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.
High Sensitivity Cardiac Troponin T using EDTA tubes
Time frame: Baseline
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.
High Sensitivity Cardiac Troponin T using EDTA tubes
Time frame: 1 hour after baseline
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.
High Sensitivity Cardiac Troponin T using EDTA tubes
Time frame: 2 hours after baseline
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.
High Sensitivity Cardiac Troponin T using EDTA tubes
Time frame: 3 hours after baseline
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.
Cardiac Troponin T (cTn)
Time frame: Baseline
Site-specific cTn will be measured at baseline
Cardiac Troponin T (cTn)
Time frame: 3 hours
Site-specific cTn will be measured at 3 hours unless baseline site-specific cTn tests positive
Occurrence of major adverse cardiac events (MACE)
Time frame: 30 days
Occurrence of major adverse cardiac events (MACE)
Time frame: 90 days
2 secondary outcomes
HEART Score Calculation
Time frame: Change from Baseline, 1, 2, 3 hours. 30 days and 90 days post discharge
Incidence and Intensity of Adverse Events
Time frame: Change from Baseline, 1, 2, 3 hours. 30 days and 90 days post discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Derived from this study: PubMed 39781769Ashburn 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.
- Derived from this study: PubMed 39729682Supples 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.
- Derived from this study: PubMed 38471727Millard 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.
- Derived from this study: PubMed 38417221Ashburn 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.
- Derived from this study: PubMed 38088463Supples 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.
- Derived from this study: PubMed 37306075Popp 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.
- Derived from this study: PubMed 37131096Neumann 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.
- Derived from this study: PubMed 33474976Allen 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.
- Individual participant dataSharing planned: No
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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.
Brandon R Allen, MD principal investigator
University of Florida
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Chest Pain, run by University of Florida at 6 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 2 inclusion and 12 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: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
High Sensitivity Cardiac Troponin T using lithium heparin tubes (time frame: Baseline). The study lists 12 primary outcomes in all. 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 NCT02984436, which also lists 8 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 17 Dec 2020.