Document Detail

Prospective evaluation of the prognostic implications of improved assay performance with a sensitive assay for cardiac troponin I.
MedLine Citation:
PMID:  20447535     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: The purpose of this study was to investigate the prognostic implications of low-level increases in cardiac troponin I (cTnI) using a current-generation sensitive assay in patients with suspected acute coronary syndrome (ACS). BACKGROUND: Recent enhancements in troponin assays have enabled resolution of the 99th percentile reference limit at progressively lower concentrations. However, the clinical significance of low-level increases with sensitive assays is still debated. METHODS: We measured cTnI using a sensitive assay (TnI-Ultra, Siemens Healthcare Diagnostics, Deerfield, Illinois) at baseline in 4,513 patients with non-ST-segment elevation ACS randomly assigned to ranolazine or placebo. We applied decision limits at the 99th percentile reference limit (0.04 microg/l), the cut point of the predecessor assay (0.1 microg/l), and 1 equivalent to elevation of creatine kinase-myocardial band (1.5 ng/ml). RESULTS: Patients with baseline cTnI > or =0.04 microg/l (n = 2,924) were at higher risk of death/myocardial infarction (MI) at 30 days than were patients with a negative cTnI (6.1% vs. 2.0%, p < 0.001). After adjusting for the TIMI (Thrombolysis In Myocardial Infarction) risk score, cTnI > or =0.04 microg/l was associated with a 3-fold (95% confidence interval: 2.0 to 4.4, p < 0.001) higher risk of death/MI at 30 days. Moreover, patients with low-level increases (0.04 microg/l to <0.1 microg/l), were at significantly higher risk of death/MI at 30 days (5.0% vs. 2.0%, p = 0.001) and death at 12 months (6.4% vs. 2.4%, p = 0.005) than were patients with cTnI <0.04 microg/l. CONCLUSIONS: Low-level increases in cTnI using a sensitive assay identify patients at higher risk of death or MI. These findings support current American College of Cardiology/American Heart Association recommendations defining MI, and the incremental value of newer, more sensitive assays in identifying high-risk patients with ACS.
Marc Bonaca; Benjamin Scirica; Marc Sabatine; Anthony Dalby; Jindrich Spinar; Sabina A Murphy; Peter Jarolim; Eugene Braunwald; David A Morrow
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Journal of the American College of Cardiology     Volume:  55     ISSN:  1558-3597     ISO Abbreviation:  J. Am. Coll. Cardiol.     Publication Date:  2010 May 
Date Detail:
Created Date:  2010-05-07     Completed Date:  2010-06-10     Revised Date:  2010-08-02    
Medline Journal Info:
Nlm Unique ID:  8301365     Medline TA:  J Am Coll Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2118-24     Citation Subset:  AIM; IM    
Copyright Information:
Copyright 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts 02115, USA.
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MeSH Terms
Acetanilides / therapeutic use
Acute Coronary Syndrome / blood*,  diagnosis*,  mortality
Biological Markers / blood
Enzyme Inhibitors / therapeutic use
Follow-Up Studies
Middle Aged
Myocardial Infarction / blood,  diagnosis,  epidemiology
Piperazines / therapeutic use
Predictive Value of Tests
Prospective Studies
Risk Factors
Troponin I / blood*
Reg. No./Substance:
0/Acetanilides; 0/Biological Markers; 0/Enzyme Inhibitors; 0/Piperazines; 0/Troponin I; 110445-25-5/ranolazine
Comment In:
J Am Coll Cardiol. 2010 May 11;55(19):2125-8   [PMID:  20447536 ]
Nat Rev Cardiol. 2010 Aug;7(8):416

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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