Finding acute coronary syndrome with serial troponin testing for rapid assessment of cardiac ischemic symptoms (FAST-TRAC): a study protocol

W Frank Peacock, Alan S Maisel, Christian Mueller, Stefan D Anker, Fred S Apple, Robert H Christenson, Paul Collinson, Lori B Daniels, Deborah B Diercks, Salvatore Di Somma, Gerasimos Filippatos, Gary Headden, Brian Hiestand, Judd E Hollander, Juan C Kaski, Joshua M Kosowsky, John T Nagurney, Richard M Nowak, Donald Schreiber, Gary M Vilke, Marvin A Wayne, Martin Than, W Frank Peacock, Alan S Maisel, Christian Mueller, Stefan D Anker, Fred S Apple, Robert H Christenson, Paul Collinson, Lori B Daniels, Deborah B Diercks, Salvatore Di Somma, Gerasimos Filippatos, Gary Headden, Brian Hiestand, Judd E Hollander, Juan C Kaski, Joshua M Kosowsky, John T Nagurney, Richard M Nowak, Donald Schreiber, Gary M Vilke, Marvin A Wayne, Martin Than

Abstract

Objective: To determine the utility of a highly sensitive troponin assay when utilized in the emergency department.

Methods: The FAST-TRAC study prospectively enrolled >1,500 emergency department patients with suspected acute coronary syndrome within 6 hours of symptom onset and 2 hours of emergency department presentation. It has several unique features that are not found in the majority of studies evaluating troponin. These include a very early presenting population in whom prospective data collection of risk score parameters and the physician's clinical impression of the probability of acute coronary syndrome before any troponin data were available. Furthermore, two gold standard diagnostic definitions were determined by a pair of cardiologists reviewing two separate data sets; one that included all local troponin testing results and a second that excluded troponin testing so that diagnosis was based solely on clinical grounds. By this method, a statistically valid head-to-head comparison of contemporary and high sensitivity troponin testing is obtainable. Finally, because of a significant delay in sample processing, a unique ability to define the molecular stability of various troponin assays is possible.

Trial registration: ClinicalTrials.gov Identifier NCT00880802.

Keywords: Acute coronary syndrome; Coronary artery disease; Emergency medicine; Myocardial infarction; Troponin.

Conflict of interest statement

No potential conflict of interest relevant to this article was reported.

References

    1. Owens PL, Barrett ML, Gibson TB, Andrews RM, Weinick RM, Mutter RL. Emergency department care in the United States: a profile of national data sources. Ann Emerg Med. 2010;56:150–65.
    1. Rui P, Kang K, Albert M. National hospital ambulatory medical care survey: 2013 emergency department summary tables [Internet] Atlanta, GA: Centers for Disease Control and Prevention; 2013. [cited 2021 Sep 2]. Available from: .
    1. Pope JH, Aufderheide TP, Ruthazer R, et al. Missed diagnoses of acute cardiac ischemia in the emergency department. N Engl J Med. 2000;342:1163–70.
    1. Pines JM, Isserman JA, Szyld D, Dean AJ, McCusker CM, Hollander JE. The effect of physician risk tolerance and the presence of an observation unit on decision making for ED patients with chest pain. Am J Emerg Med. 2010;28:771–9.
    1. Fleischmann KE, Goldman L, Johnson PA, et al. Critical pathways for patients with acute chest pain at low risk. J Thromb Thrombolysis. 2002;13:89–96.
    1. Roger VL, Go AS, Lloyd-Jones DM, et al. Heart disease and stroke statistics: 2011 update: a report from the American Heart Association. Circulation. 2011;123:e18–209.
    1. Gomez MA, Anderson JL, Karagounis LA, Muhlestein JB, Mooers FB. An emergency department-based protocol for rapidly ruling out myocardial ischemia reduces hospital time and expense: results of a randomized study (ROMIO) J Am Coll Cardiol. 1996;28:25–33.
    1. Thygesen K, Alpert JS, Jaffe AS, et al. Fourth universal definition of myocardial infarction (2018) J Am Coll Cardiol. 2018;72:2231–64.
    1. Apple FS, Collinson PO. Analytical characteristics of high-sensitivity cardiac troponin assays. IFCC Task Force on Clinical Applications of Cardiac Biomarkers. Clin Chem. 2012;58:54–61.
    1. Nestelberger T, Boeddinghaus J, Wussler D, et al. Predicting major adverse events in patients with acute myocardial infarction. J Am Coll Cardiol. 2019;74:842–54.
    1. Than MP, Aldous SJ, Troughton RW, et al. Detectable high-sensitivity cardiac troponin within the population reference interval conveys high 5-year cardiovascular risk: an observational study. Clin Chem. 2018;64:1044–53.
    1. Hollander JE, Blomkalns AL, Brogan GX, et al. Standardized reporting guidelines for studies evaluating risk stratification of emergency department patients with potential acute coronary syndromes. Ann Emerg Med. 2004;44:589–98.
    1. Schoenfeld DA, Gelber RD. Designing and analyzing clinical trials which allow institutions to randomize patients to a subset of the treatments under study. Biometrics. 1979;35:825–9.

Source: PubMed

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