Alan B Storrow1, Robert H Christenson2, Richard M Nowak3, Deborah B Diercks4, Adam J Singer5, Alan H B Wu6, Erik Kulstad7, Frank LoVecchio8, Christian Fromm9, Gary Headden10, Tracie Potis11, Christopher J Hogan12, Jon W Schrock13, Daniel P Zelinski14, Marna R Greenberg15, James C Ritchie16, Janna S Chamberlin17, Kurtis R Bray17, Daniel W Rhodes17, Deirdre Trainor17, Dawn Holmes17, Paula C Southwick17. 1. Dept. of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: alan.storrow@vanderbilt.edu. 2. Dept. of Pathology, University of Maryland Medical Center, Baltimore, MD, USA. 3. Dept. of Emergency Medicine, Henry Ford Health System, Detroit, MI, USA. 4. Dept. of Emergency Medicine, University of California Davis, Sacramento, CA, USA. 5. Dept. of Emergency Medicine, State University of New York at Stony Brook, Stony Brook, NY, USA. 6. Clinical Chemistry Laboratory, San Francisco General Hospital, University of California, San Francisco, CA, USA. 7. Dept. of Emergency Medicine, Advocate Christ Medical Center, Oak Lawn, IL, USA. 8. Dept. of Emergency Medicine, Maricopa Medical Center, Phoenix, AZ, USA. 9. Dept. of Emergency Medicine, Maimonides Medical Center, Brooklyn, NY, USA. 10. Chest Pain Center, Medical University of South Carolina, Charleston, SC, USA. 11. Dept. of Emergency Medicine, Covenant Medical Center, Saginaw, MI, USA. 12. Dept. of Emergency Medicine, Virginia Commonwealth University Medical Center, Richmond, VA, USA. 13. Dept. of Emergency Medicine, Case Western Reserve University School of Medicine, MetroHealth Medical Center, Cleveland, OH, USA. 14. Dept. of Emergency Medicine, The Ohio State University Medical Center, Columbus, OH, USA. 15. Dept. of Emergency Medicine, Lehigh Valley Health Network, Allentown, PA, USA. 16. Dept. of Pathology and Laboratory Medicine, Emory University, Atlanta, GA, USA. 17. Dept. of Clinical Research, Beckman Coulter, Inc., Carlsbad, CA, USA.
Abstract
OBJECTIVES: To compare emergency department TnI serial sampling intervals, determine optimal diagnostic thresholds, and report representative diagnostic performance characteristics for early rule-in and rule-out of MI. METHODS: We prospectively measured TnI (AccuTnI+3™, Beckman Coulter) at serial time intervals in 1929 subjects with chest pain or equivalent ischemic symptoms suggestive of acute coronary syndromes at 14 medical centers. Diagnosis was adjudicated by an independent central committee. RESULTS: TnI ≥0.03ng/mL provided 96.0% sensitivity and 89.4% specificity at 1-3h after admission, and 94.9% sensitivity and 86.7% specificity at 3-6h. NPV (rule-out, non-MI) was 99.5% at 1-3h, and 99.0% at 3-6h when TnI is <0.03ng/mL. NPV was 99.1% when TnI is <0.03ng/mL and time of symptom onset is ≥8h. Approximately 50-58% (PPV) of patients with TnI ≥0.03ng/mL were diagnosed with MI, depending upon time from onset or admission; PPVs emphasize the importance of serial samples and delta TnI (rising or falling pattern) when low cutoffs are used. Nevertheless, even a single elevated TnI value increased the risk of MI. As TnI values rose, the probability of MI increased. Values ≥0.20ng/mL were associated with nearly 90% probability of MI. CONCLUSIONS: We report a large multicenter prospective adjudicated trial assessing troponin for early rule-in and rule-out using the Universal Definition of MI and conducted in primary care hospital-associated emergency departments. Our study demonstrates high diagnostic accuracy at early observation times, and reinforces consensus recommendations for sampling on admission and 3h later, repeated at 6h when clinical suspicion remains high.
OBJECTIVES: To compare emergency department TnI serial sampling intervals, determine optimal diagnostic thresholds, and report representative diagnostic performance characteristics for early rule-in and rule-out of MI. METHODS: We prospectively measured TnI (AccuTnI+3™, Beckman Coulter) at serial time intervals in 1929 subjects with chest pain or equivalent ischemic symptoms suggestive of acute coronary syndromes at 14 medical centers. Diagnosis was adjudicated by an independent central committee. RESULTS: TnI ≥0.03ng/mL provided 96.0% sensitivity and 89.4% specificity at 1-3h after admission, and 94.9% sensitivity and 86.7% specificity at 3-6h. NPV (rule-out, non-MI) was 99.5% at 1-3h, and 99.0% at 3-6h when TnI is <0.03ng/mL. NPV was 99.1% when TnI is <0.03ng/mL and time of symptom onset is ≥8h. Approximately 50-58% (PPV) of patients with TnI ≥0.03ng/mL were diagnosed with MI, depending upon time from onset or admission; PPVs emphasize the importance of serial samples and delta TnI (rising or falling pattern) when low cutoffs are used. Nevertheless, even a single elevated TnI value increased the risk of MI. As TnI values rose, the probability of MI increased. Values ≥0.20ng/mL were associated with nearly 90% probability of MI. CONCLUSIONS: We report a large multicenter prospective adjudicated trial assessing troponin for early rule-in and rule-out using the Universal Definition of MI and conducted in primary care hospital-associated emergency departments. Our study demonstrates high diagnostic accuracy at early observation times, and reinforces consensus recommendations for sampling on admission and 3h later, repeated at 6h when clinical suspicion remains high.
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