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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 Circulation
2015 ; 131
(23
): 2032-40
Nephropedia Template TP
gab.com Text
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Twit Text #
English Wikipedia
Misdiagnosis of Myocardial Infarction Related to Limitations of the Current
Regulatory Approach to Define Clinical Decision Values for Cardiac Troponin
#MMPMID25948541
Wildi K
; Gimenez MR
; Twerenbold R
; Reichlin T
; Jaeger C
; Heinzelmann A
; Arnold C
; Nelles B
; Druey S
; Haaf P
; Hillinger P
; Schaerli N
; Kreutzinger P
; Tanglay Y
; Herrmann T
; Moreno Weidmann Z
; Krivoshei L
; Freese M
; Stelzig C
; Puelacher C
; Rentsch K
; Osswald S
; Mueller C
Circulation
2015[Jun]; 131
(23
): 2032-40
PMID25948541
show ga
BACKGROUND: Misdiagnosis of acute myocardial infarction (AMI) may significantly
harm patients and may result from inappropriate clinical decision values (CDVs)
for cardiac troponin (cTn) owing to limitations in the current regulatory
process. METHODS AND RESULTS: In an international, prospective, multicenter
study, we quantified the incidence of inconsistencies in the diagnosis of AMI
using fully characterized and clinically available high-sensitivity (hs) cTn
assays (hs-cTnI, Abbott; hs-cTnT, Roche) among 2300 consecutive patients with
suspected AMI. We hypothesized that the approved CDVs for the 2 assays are not
biologically equivalent and might therefore contribute to inconsistencies in the
diagnosis of AMI. Findings were validated by use of sex-specific CDVs and
parallel measurements of other hs-cTnI assays. AMI was the adjudicated diagnosis
in 473 patients (21%). Among these, 86 patients (18.2%) had inconsistent
diagnoses when the approved uniform CDV was used. When sex-specific CDVs were
used, 14.1% of female and 22.7% of male AMI patients had inconsistent diagnoses.
Using biologically equivalent CDV reduced inconsistencies to 10% (P<0.001). These
findings were confirmed with parallel measurements of other hs-cTn assays. The
incidence of inconsistencies was only 7.0% for assays with CDVs that were nearly
biologically equivalent. Patients with inconsistent AMI had long-term mortality
comparable to that of patients with consistent diagnoses (P=NS) and a trend
toward higher long-term mortality than patients diagnosed with unstable angina
(P=0.05). CONCLUSIONS: Currently approved CDVs are not biologically equivalent
and contribute to major inconsistencies in the diagnosis of AMI. One of 5 AMI
patients will receive a diagnosis other than AMI if managed with the alternative
hs-cTn assay. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov.
Unique identifier: NCT00470587.
|Aged
[MESH]
|Aged, 80 and over
[MESH]
|Biomarkers/blood
[MESH]
|Diagnostic Errors/*statistics & numerical data
[MESH]