Diagnostic accuracy of a point-of-care troponin I assay for acute myocardial infarction within 3 hours after presentation in early presenters to the emergency department with chest pain

2012 ◽  
Vol 163 (1) ◽  
pp. 74-80.e4 ◽  
Author(s):  
Deborah B. Diercks ◽  
W. Frank Peacock ◽  
Judd E. Hollander ◽  
Adam J. Singer ◽  
Robert Birkhahn ◽  
...  
2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
C Hansen ◽  
C Bang ◽  
K G Lauridsen ◽  
C A Frederiksen ◽  
M Schmidt ◽  
...  

Abstract Introduction According to ESC guidelines, an acute myocardial infarction (MI) can be excluded without serial troponin measurements in patients presenting with a single high-sensitive troponin below the 99th percentile and chest pain starting >6 hours prior to admission. However, it is unclear if single-testing of high-sensitive troponin can rule-out MI in early presenters. Purpose To investigate the diagnostic performance of a single value of high-sensitive cardiac troponin I (hs-cTnI) at presentation for ruling-out MI in patients presenting with chest pain to the Emergency Department irrespective of chest pain onset. Methods We conducted a substudy of preliminary data from the RACING-MI trial. We included patients presenting with chest pain suggestive of MI to the Emergency Department of a Regional Hospital. We used the Siemens hs-cTnI (Siemens Healthcare, TNIH, Limit of detection: 2.21 ng/L) and a diagnostic cut-off value <3 ng/L to rule-out MI at presentation. Two physicians independently adjudicated the final diagnosis based on all clinical information. Patients were stratified based on time from chest pain onset to hospital admission as very early (0–3 hours), early (3–6 hours) and late presenters (>6 hours). Results We included 989 patients with available hs-cTnI results at admission. MI was confirmed in 82 (8.3%) patients. Using hs-cTnI <3 ng/L as diagnostic cut-off value at presentation, 302 (30.5%) patients without MI were classified as rule-out. Overall, the negative predictive value (NPV) for MI was 100% (95% CI 98.7–100). Based on chest pain onset, 33.8% of patients were classified as very early, 12.8% as early, and 42.7% as late presenters, with 10.7% patients with unreported/unknown onset. NPV was 100% (95% CI 96.5–100) for very early, 100% (95% CI 88.3–100) for early and 100% (95% CI 97.3–100) for late presenters. Conclusions Using a single hs-cTnI value <3ng/L as diagnostic cut-off to rule-out MI seems to be safe and to allow rapid rule-out of MI in patients presenting with chest pain to the emergency department, even in very early presenters. ClinicalTrials.gov Identifier: NCT03634384. Acknowledgement/Funding Randers Regional Hospital, A.P Møller Foundation, Boserup Foundation, Korning Foundation, Højmosegård Grant, Siemens Healthcare (TNIH assays), etc.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
J Boeddinghaus ◽  
T Nestelberger ◽  
R Twerenbold ◽  
L Koechlin ◽  
D Wussler ◽  
...  

Abstract Background Lately, the novel high-sensitivity cardiac troponin I (hs-cTnI) Access assay was developed. Its clinical performance in patients presenting with chest pain to the emergency department (ED) is unknown. Purpose To clinically validate the novel hs-cTnI-Access assay and to derive and validate an assay specific 0/1h-algorithm accordingly to the European Society of Cardiology (ESC) recommendations. Methods In a prospective international multicentre study we enrolled patients presenting to the emergency department with symptoms suggestive of acute myocardial infarction (AMI). Final diagnoses were centrally adjudicated by two independent cardiologists including all clinical information including cardiac imaging twice: first, using serial hs-cTnT (Elecsys, primary analysis) and second, using hs-cTnI (Architect, secondary analysis) measurements in addition to the clinically used (hs)-cTn. Hs-cTnI-Access was measured at presentation and at 1h. Primary objective was a direct comparison of diagnostic accuracy as quantified by the area under the receiver-operating-characteristic curve (AUC) of hs-cTnI-Access versus the two established hs-cTn assays (hs-cTnT-Elecsys, hs-cTnI-Architect). Secondary objectives included the derivation and internal validation of an hs-cTnI-Access specific 0/1h-algorithm. Results AMI was the adjudicated final diagnosis in 243/1579 (15.4%) patients. The AUC at presentation for hs-cTnI-Access was 0.95 (95% CI, 0.94–0.96), significantly higher as hs-cTnI-Architect (0.92 [95% CI, 0.91–0.94; p<0.001]), and comparable to hs-cTnT-Elecsys (0.94 [95% CI, 0.93–0.95; p=0.12]) Applying the derived hs-cTnI-Access 0/1h-algorithm (derivation cohort n=686) to the internal validation cohort (n=680), 60% of patients were ruled-out (sensitivity 98.9% [95% CI, 94.3–99.8]), and 15% of patients were ruled-in (specificity 95.9% [95% CI, 94.0–97.2]). Patients ruled-out by the 0/1h-algorithm had a survival rate of of 100% after 30-days and 98.4% after two years of follow up. Findings were confirmed in the secondary analyses using the adjudication including serial measurements of hs-cTnI (Architect). Performance of the 0/1h-algorithm Conclusions Diagnostic accuracy of the novel hs-cTnI-Access assay is excellent and at least comparable to the two established hs-cTn assays. The assay-specific 0/1h-algorithm allows a safe rule-out and accurate rule-in of MI in about 75% of patients within 1-hour after presentation to the ED. Survival of patients ruled-out by the 0/1h-algorithm was very high. Acknowledgement/Funding Swiss National Science Foundation, the Swiss Heart Foundation, the KTI, the European Union, the Stiftung für kardiovaskuläre Forschung Basel


2021 ◽  
Vol 15 (11) ◽  
pp. 3346-3348
Author(s):  
Fareeha Cheema ◽  
Zahid Mahmood ◽  
Nasir Iqbal ◽  
Hassan Jamil ◽  
Saima Rubab Khan ◽  
...  

Introduction: Acute myocardial infarction causes significant mortality and morbidity. Timely conclusion permits clinicians to risk stratify their patients and select suitable treatment. Biomarkers have been utilized to help with timely decision, whereas an expanding number of novel markers have been recognized to predict result taking after an acute myocardial infarction or acute coronary disorder. This may encourage tailoring of appropriate treatment to high-risk patients. This survey focuses on an assortment of promising biomarkers which give symptomatic and prognostic data. Objective: To compare the early demonstrative efficiency of the cardiac troponin I (cTn-I) level with that of the cardiac troponin T (cTn-T) level, as well as the creatine kinase (CK), CK-MB, and myoglobin levels, for acute myocardial infarction (AMI) in patients without an initially diagnostic ECG presenting to the Emergency department within 24 hours of the onset of their symptoms. Material and Methods Study design: Prospective Observational Cohort Settings: Punjab Institute of Cardiology Duration: Six months i.e. 1st January 2020 to 30th June 2020 Data Collection procedure: A planned, observational, cohort study was performed including chest pain patients admitted to territory care hospital. Members were sequential consenting through Emergency department with chest pain and age more than 30 years. Exclusion included having symptoms >24 hours, failure to total information collection, receipt of CPR, and ST-segment elevation on the starting ECG. Estimations included levels of Trop-I, Trop- T, CK, CK-MB, and myoglobin at the time of introduction and 1, 2, 6, and 12-24 hours after presentation as well as showing ECG and clinical follow-up. The collected data was analyzed by using SPSS version 23. Results: 140 included for study out of the 200 patients, 21 (14%) were analyzed as having acute myocardial infarction after diagnostic ECG testing. The sensitivities of all 5 biochemical markers for acute myocardial infarction were poor at the time of emergency department induction. The sensitivity of Trop-T was essentially superior to that of Trop-I over the starting 2 hours (3.2-33.1), but both markers' sensitivities were low (<60%) during this time outline. The Trop-I was significantly more particular for acute myocardial infarction than was the Trop-T, but not essentially better than CK-MB or myoglobin. Likelihood proportion analysis appeared that the biochemical markers with the most elevated positive ratios for acute myocardial infarction amid the primary 2 hours taking after emergency department admission were myoglobin and CK-MB. From 6 through 24 hours, the positive probability proportions for Trop I, CK-MB, and myoglobin were predominant to those of CK and Trop-T. Conclusion: Trop-I, CK-MB, and myoglobin are essentially more particular for acute myocardial infarction than are CK and Trop-T. Myoglobin is the biochemical marker having the most elevated combination of sensitivity, specificity, and negative predictive value for acute myocardial infarction inside 2 hours of emergency department induction. Not one or the other Trop-I nor Trop-T offers significant advantages over myoglobin and CK-MB within the early less than 2 hours starting screening for acute myocardial infarction. The cardiac troponins are of advantage in recognizing acute myocardial infarction greater than 6 hours after presentation. Key words: Myocardial Infarction, CKMB, Trop t, Trop I, Myoglobin


Cardiology ◽  
2020 ◽  
pp. 1-8
Author(s):  
Ronny Alcalai ◽  
Boris Varshisky ◽  
Ahmad Marhig ◽  
David Leibowitz ◽  
Larissa Kogan-Boguslavsky ◽  
...  

<b><i>Background:</i></b> Early and accurate diagnosis of acute coronary syndrome (ACS) is essential for initiating lifesaving interventions. In this article, the diagnostic performance of a novel point-of-care rapid assay (SensAheart<sup>©</sup>) is analyzed. This assay qualitatively determines the presence of 2 cardiac biomarkers troponin I and heart-type fatty acid-binding protein that are present soon after onset of myocardial injury. <b><i>Methods:</i></b> We conducted a prospective observational study of consecutive patients who presented to the emergency department with typical chest pain. Simultaneous high-sensitive cardiac troponin T (hs-cTnT) and SensAheart testing was performed upon hospital admission. Diagnostic accuracy was computed using SensAheart or hs-cTnT levels versus the final diagnosis defined as positive/negative. <b><i>Results:</i></b> Of 225 patients analyzed, a final diagnosis of ACS was established in 138 patients, 87 individuals diagnosed with nonischemic chest pain. In the overall population, as compared to hs-cTnT, the sensitivity of the initial SensAheart assay was significantly higher (80.4 vs. 63.8%, <i>p</i> = 0.002) whereas specificity was lower (78.6 vs. 95.4%, <i>p</i> = 0.036). The overall diagnostic accuracy of SensAheart assay was similar to the hs-cTnT (82.7% compared to 76.0%, <i>p</i> = 0.08). <b><i>Conclusions:</i></b> Upon first medical contact, the novel point-of-care rapid SensAheart assay shows a diagnostic performance similar to hs-cTnT. The combination of 2 cardiac biomarkers in the same kit allows for very early detection of myocardial damage. The SensAheart assay is a reliable and practical tool for ruling-in the diagnosis of ACS.


Author(s):  
Mahir Abdulkadhum Khudhair Alzughaibi ◽  
Ammar Waheeb Obeiad ◽  
Nassar Abdalaema Abdalhadi Mera ◽  
Mohammed Sadeq Hamzah Al-Ruwaiee

Background: Cardiac Troponins-I (CTNI) are myoregulatory polypeptides that control the actin-myosin interface, considered specific to cardiomyocytes. Age and sex variances in the extent of CTNI levels have arisen a recent debatable emphasis. Existing revisions do not display a reliable clinical power of sex-specific CTNI 99th centiles, which actually might mirror procedural aspects. Nevertheless, from a biochemical viewpoint, the trends of sex-specific CTNI 99th centiles seem sensible for the ruling-in of acute myocardial infarction AMI. Vulnerable females may be missed when applying the male sex-specific threshold. This study aimed to determine whether gender differences in CTNI exist in patients with AMI presented with chest pain. Methodology: The study was a cross-sectional, single-center, included 236-patients with AMI diagnosis by cardiologists at Merjan teaching hospital during the period from April to July 2020 from patients attending the hospital for cardiac consultation complaining of acute chest pain suggestive of AMI. Blood analysis had initiated at the time of admission included serum creatinine, blood urea, R/FBS, WBCs, PCV, and serum CTNI. A p-value below 0.05 specifies statistical significance. All statistical bioanalyses had performed by IBM-SPSS, version-25 for Windows. Results: The mean age of participants was 67.5 years, the men were dominant 76.2%. The incidence of DM and hypertension were significantly high and 24.5% of the patients were current smokers. Biochemical serum analysis revealed mean creatinine, urea, sugar, and STI values were 79.8±4.2 mmol/l, 15.9±1.7 mmol/l, 10.9±0.9 mmol/l, and 7.9±0.6 ng/ml separately. Both hypertension and smoking were significantly (p-0.001) more among males compared to the females, which is not the case for the prevalence of DM. The males were heavier significantly than females (p-0.001). Almost, there was no impact of gender on most of the other study variables other than serum TNI levels, which were significantly higher among the males (p-0.001). Conclusion: In patients with AMI presented with acute chest pain, the routine of CTNI in the diagnosis of AMI is based on the patient's gender. The application of gender-dependent cutoff levels for CTNI analyses appears to be highly suggested.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Aldous ◽  
J Pickering ◽  
J Young ◽  
P George ◽  
A Watson ◽  
...  

Abstract Background High sensitivity troponin assays were developed to improve analytical sensitivity and precision at the decision cut-points for the diagnosis and rule out of acute myocardial infarction (AMI). Central laboratory assays have achieved this but point of care assays, which have the ability to accelerate decision making due to much shorter turnaround times, have remained lacking. Purpose To ascertain the threshold for decision making and subsequent clinical utility for ruling out AMI on presentation in patients attending the emergency department acutely with chest pain, using a high precision point of care troponin assay (TnI Nx), (i-STAT, Abbott). Methods We measured arrival TnI-Nx concentrations in stored plasma samples in adults presenting acutely to the emergency department with chest pain. The primary outcome was an AMI or cardiac death on index admission or within 30 days. We used 2000 bootstrapped data sets to derive and validate a suitable threshold for TnI-Nx before calculating diagnostic test performance. We pre-specified this threshold must have a <1% false negative rate for the primary outcome. We compared this with a core laboratory high sensitivity troponin I (hs-TnI) (Abbott Architect) using the early rule-out cut-point (European Society of Cardiology) at the limit of detection (2 ng/L). Results We recruited 1320 patients of whom 192 (14.1%) had the primary outcome. The TnI-Nx threshold was determined to be 8 ng/L with subsequent sensitivity of 99.0% (95% confidence interval: 97.3% to 100%), negative predictive value of 99.7% (99.2% to 100%) and specificity of 59.0% (56.0% to 62.0%). The hs-TnI had a sensitivity of 99.5% (98.2% to 100%), negative predictive value of 99.7% (99.0% to 100%), and specificity of 28.4% (25.8% to 31.2%) at 2ng/L. Conclusion A high precision point of care assay, TnI-Nx, with a decision threshold of 8ng/L, has comparable rule out performance compared with a core laboratory high sensitivity assay and therefore could potentially be used for early decision making in the assessment of acute chest pain. Acknowledgement/Funding Research grant from Abbott Point of Care. Senior Research Fellowship from ECF, CMRF and CDHB. Clinical Research Fellowship from NZ HRC


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