High-Sensitivity Cardiac Troponin T to OPtimize Chest Pain Risk Stratification



Status:Active, not recruiting
Conditions:Angina, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - Any
Updated:1/16/2019
Start Date:January 25, 2017
End Date:March 2019

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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.

Inclusion Criteria:

1. Age greater than or equal to 21 years at the time of enrollment in the ED

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:

1. New ST-segment elevation consistent with myocardial infarction

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
We found this trial at
6
sites
Sacramento, California 95817
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Gainesville, Florida 32610
(352) 392-3261
Phone: 352-265-5911
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Detroit, Michigan 48202
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Detroit, MI
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Winston-Salem, North Carolina 27157
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Winston-Salem, NC
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