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.
Study Type
OBSERVATIONAL
Enrollment
1,572
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.
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Wake Forest University
Winston-Salem, North Carolina, United States
University of Utah
Salt Lake City, Utah, United States
Time frame: 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.
Time frame: 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.
Time frame: 3 hours after baseline
Cardiac Troponin T (cTn)
Site-specific cTn will be measured at baseline
Time frame: Baseline
Cardiac Troponin T (cTn)
Site-specific cTn will be measured at 3 hours unless baseline site-specific cTn tests positive
Time frame: 3 hours
Occurrence of major adverse cardiac events (MACE)
Time frame: 30 days
Occurrence of major adverse cardiac events (MACE)
Time frame: 90 days
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
Time frame: 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
Time frame: Change from Baseline, 1, 2, 3 hours. 30 days and 90 days post discharge