NCT02984436

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,572

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 7, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 25, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

2.9 years

First QC Date

December 1, 2016

Last Update Submit

December 15, 2020

Conditions

Acute Coronary SyndromeChest Pain

Outcome Measures

Primary Outcomes (12)

  • 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

    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

Secondary Outcomes (2)

  • HEART Score Calculation

    Change from Baseline, 1, 2, 3 hours. 30 days and 90 days post discharge

  • Incidence and Intensity of Adverse Events

    Change from Baseline, 1, 2, 3 hours. 30 days and 90 days post discharge

Study Arms (1)

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.

Procedure: Blood SampleBehavioral: HEART Score

Interventions

Blood SamplePROCEDURE

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.

Also known as: Blood draw
ED Patients with Acute Chest Pain
HEART ScoreBEHAVIORAL

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.

Also known as: HEART Pathway
ED Patients with Acute Chest Pain

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients 21 years of age or older with possible Acute Coronary Syndrome (ACS) and associated chest pain.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

UC Davis

Sacramento, California, 95817, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27109, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (7)

  • 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.

    PMID: 39781769DERIVED

  • 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.

    PMID: 39729682DERIVED

  • 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.

    PMID: 38471727DERIVED

  • 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.

    PMID: 38417221DERIVED

  • 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.

    PMID: 38088463DERIVED

  • 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.

    PMID: 37131096DERIVED

  • 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.

    PMID: 33474976DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeChest Pain

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Brandon R Allen, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2016

First Posted

December 7, 2016

Study Start

January 25, 2017

Primary Completion

December 31, 2019

Study Completion

September 30, 2020

Last Updated

December 17, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

US(6)