scholarly journals Diagnostic Accuracy of a New High-Sensitivity Troponin I Assay and Five Accelerated Diagnostic Pathways for Ruling Out Acute Myocardial Infarction and Acute Coronary Syndrome

2018 ◽  
Vol 71 (4) ◽  
pp. 439-451.e3 ◽  
Author(s):  
Jaimi H. Greenslade ◽  
Edward W. Carlton ◽  
Christopher Van Hise ◽  
Elizabeth Cho ◽  
Tracey Hawkins ◽  
...  
Author(s):  
Sally J. Aldous ◽  
Chris M. Florkowski ◽  
Ian G. Crozier ◽  
Martin P. Than

AbstractMany papers evaluating high sensitivity troponin assays make the diagnosis of myocardial infarction based on conventional troponin assays in clinical use at the time of recruitment. Such analyses often do not show superiority of high sensitivity assays compared with contemporary assays meeting precision guidelines.Three hundred and twenty-two patients presenting to the emergency department between November 2006 and April 2007 for evaluation for acute coronary syndrome had serial (0 h and >6 h) bloods taken to compare troponin assays (Roche hsTnT, Abbott TnI, Roche TnT and Vitros TnI). The diagnosis of myocardial infarction was made using each troponin assay separately with which that same assay was analysed for diagnostic performance.The rate of myocardial infarction would be 38.9% using serial hsTnT, 31.3% using serial Abbott TnI, 27.1% using serial TnT and 26.4% using serial Vitros TnI. The baseline sensitivities (0 h) are 89.9% (85.2–93.3) for hsTnT, 77.9% (71.0–87.5) for Abbott TnI, 73.0% (65.6–78.7) for TnT and 86.8% (74.6–94.4%) for Vitros TnI. The specificities (peak 0 h and >6 h samples) are 93.1% (91.2–93.1) for hsTnT, 88.3% (86.5–88.3) for Abbott TnI, 92.2% (90.5–92.2) for TnT and 90.6% (70.1–90.6) for Vitros TnI.hsTnT has superior sensitivity for myocardial infarction than even assays at or near guideline precision requirements (Abbott and Vitros TnI). The specificity of hsTnT assay is not as poor as previous analyses suggest.


Author(s):  
Paul Simpson ◽  
Rosy Tirimacco ◽  
Penelope Cowley ◽  
May Siew ◽  
Narelle Berry ◽  
...  

Background The management of patients presenting with symptoms suggestive of acute coronary syndrome is a significant challenge for clinicians. Guidelines for the diagnosis of acute myocardial infarction require a rise and/or fall of cardiac troponin, along with other criteria. Knowing what constitutes a significant delta change from baseline is still unclear and the literature is varied. Methods We compared three methods for determining cardiac troponin delta changes (relative, absolute and z-scores) for detecting acute myocardial infarction in 806 patients presenting to an emergency department with symptoms suggestive of acute coronary syndrome. Blood specimens were collected at admission and 2, 3, 4 and 6 h postadmission and tested on the Roche Elecsys high-sensitivity troponin T assay. Results A positive diagnosis for acute myocardial infarction was found in 39 (4.8%) patients. ROC AUC showed better performance for the absolute and z-score delta change (0.959–0.988 and 0.956–0.988, respectively) compared with relative delta change (0.921–0.960) at all time points in the diagnosis of acute myocardial infarction. Optimal timing for the second sample was at 4–6 h postadmission. Conclusions Although not statistically significant, the results show a trend of absolute and z-score delta change performing better than relative delta change for the diagnosis of acute myocardial infarction. The z-score approach allows for a single cut-off value across multiple high-sensitivity assays which could be useful in the clinical setting. Our study also highlighted the importance of interpreting cardiac troponin changes in the clinical context with a combination of the patient’s clinical history and electrocardiogram.


2017 ◽  
Vol 63 (1) ◽  
pp. 394-402 ◽  
Author(s):  
Johannes Tobias Neumann ◽  
Nils Arne Sörensen ◽  
Francisco Ojeda ◽  
Tjark Schwemer ◽  
Jonas Lehmacher ◽  
...  

Abstract AIMS Serial measurements of high-sensitivity troponin are used to rule out acute myocardial infarction (AMI) with an assay specific cutoff at the 99th percentile. Here, we evaluated the performance of a single admission troponin with a lower cutoff combined with a low risk electrocardiogram (ECG) to rule out AMI. METHODS Troponin I measured with a high-sensitivity assay (hs-TnI) was determined at admission in 1040 patients presenting with suspected AMI (BACC study). To rule out AMI we calculated the negative predictive value (NPV) utilizing the optimal hs-TnI cutoff combined with a low risk ECG. The results were validated in 3566 patients with suspected AMI [2-h Accelerated Diagnostic Protocol to Assess Patients With Chest Pain Symptoms Using Contemporary Troponins as the Only Biomarker (ADAPT) studies]. Patients were followed for 6 or 12 months. RESULTS 184 of all patients were diagnosed with AMI. An hs-TnI cutoff of 3 ng/L resulted in a NPV of 99.3% (CI 97.3–100.0), ruling out 35% of all non-AMI patients. Adding the information of a low risk ECG resulted in a 100% (CI 97.5–100.0) NPV (28% ruled out). The 2 validation cohorts replicated the high NPV of this approach. The follow-up mortality in the ruled out population was low (0 deaths in BACC and Stenocardia, 1 death in ADAPT). CONCLUSIONS A single hs-TnI measurement on admission combined with a low risk ECG appears to rule out AMI safely without need for serial troponin testing. Trial Registration: www.clinicaltrials.gov (NCT02355457).


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
D A Psyrakis ◽  
J Bormann ◽  
B Von Jeinsen ◽  
J S Wolter ◽  
M Weferling ◽  
...  

Abstract Background Acute myocardial infarction (MI) is associated with high morbidity and mortality. A robust differentiation between type 1 and type 2 MI (T1/T2MI) has prognostic and therapeutic implications. We investigated whether serial high-sensitivity cardiac troponin I measurements could reliably discriminate T1MI from T2MI in patients presenting with a non-ST elevation myocardial infarction (NSTEMI). Methods We used data from a prospective acute coronary syndrome biomarker registry of patients with suspected MI that presented at or were transferred to one of two study centres. Here, we analysed an unselected group of 265 NSTEMI patients (67.2% males). Blood was drawn on admission and after 3 hours. High-sensitivity troponin I (hs-cTnI) was measured in frozen samples by a technician blinded to patient characteristics. T1MI or T2MI was defined as the gold-standard study diagnosis by two independent cardiologists based on all available data according to the Third Universal Definition of MI. Results A diagnosis of T2MI was made in 55 patients (20.8%) in the NSTEMI cohort. T2MI patients did not differ from T1MI patients regarding age, gender, traditional risk factors, or percentage of those with a history of coronary artery disease. Median baseline hs-cTnI levels were higher in T1MI (436.25; IQR 63.7–1918.8 ng/L) than in T2MI patients (48.4; IQR 11.7–305.9 ng/L; p<0.001). Absolute change in hs-cTnI concentration between 0 and 3 h was greater in T1MI than in T2MI patients with Dhs-cTnI 93.6 ng/L (IQR 13.5–815.3 ng/L) vs. 20.4 ng/L (IQR 2.5–106.5 ng/L) (p<0.001). hs-cTnI yielded an area under the receiver operator characteristics (AUROC) curve for identifying T2MI at baseline of 0.71 (IQR 0.64–0.79) and after 3 h of 0.7 (IQR 0.61–0.78).Dhs-cTnI was associated with an AUROC of 0.68 (IQR 0.6–0.76). Regarding a rule-out approach, Youden-optimized cut-offs for hs-cTnI at baseline as well as for the absolute change in hs-cTnI concentration were calculated (186.5 ng/L; 154.4 ng/L). Use of these two criteria yielded a sensitivity of 89% (78–96%) and a negative predictive value of 95% (89–98%) to exclude T2MI. 49 of 55 T2MI patients would have been ruled out using this algorithm. Conclusion Our data show that hs-cTnI concentrations differ between patients presenting with T1 and T2MI. The concentration of hs-cTnI and its change over time has the potential to rule out T2MI and therefore to identify patients who might benefit from an early invasive management. The differentiation between T1MI and T2MI by using hs-cTnI is nevertheless challenging, and further research on specific algorithms is needed. Acknowledgement/Funding 3German Center for Cardiovascular Research (DZHK), Partnersite Rhein Main, Bad Nauheim, Germany


2015 ◽  
Vol 156 (24) ◽  
pp. 964-971
Author(s):  
Ferenc Kovács ◽  
Ibolya Kocsis ◽  
Marina Varga ◽  
Enikő Sárváry ◽  
György Bicsák

Introduction: Cardiac biomarkers have a prominent role in the diagnosis of acute myocardial infarction. Aim: The aim of the authors was to study the diagnostic effectiveness of automated measurement of cardiac biomarkers. Method: Myeloperoxidase, high-sensitivity C-reactive protein, myoglobin, heart-type fatty acid binding protein, creatine kinase, creatine kinase MB, high-sensitivity troponin I and T were measured. Results: The high-sensitivity troponin I was the most effective (area under curve: 0.86; 95% confidence interval: 0.77–0.95; p<0.001) for the diagnosis of acute myocardial infarction. Considering a critical value of 0.35 ng/mL, its sensitivity and specificity were 81%, and 74%, respectively. Combined evaluation of the high-sensitivity troponin T and I, chest pain, and the electrocardiogram gave the best results for separation of acute myocardial infarction from other diseases (correct classification in 62.5% and 98.9% of patients, respectively). Conclusions: Until a more sensitive and specific cardiac biomarker becomes available, the best method for the diagnosis of acute myocardial infarction is to evaluate electrocardiogram and biomarker concentration and to repeat them after 3–6 hours. Orv. Hetil., 2015, 156(24), 964–971.


Cardiology ◽  
2021 ◽  
pp. 1-7
Author(s):  
Masayuki Shiozaki ◽  
Kenji Inoue ◽  
Satoru Suwa ◽  
Chien-Chang Lee ◽  
Shuo-Ju Chiang ◽  
...  

<b><i>Introduction:</i></b> Current assays based on the 0-hour/1-hour (0-/1-h) algorithm using high-sensitivity cardiac troponin (hs-cTn) are limited to only Abbott Architect hs-cTnI, Siemens Vista hs-cTnI, and Roche Elecsys hs-cTnT. <b><i>Objective:</i></b> This study aimed to evaluate this new hs-cTnI assay, LumipulsePresto hs Troponin I, for diagnosis of acute myocardial infarction (AMI) on admission and on 0-/1-h algorithm to stratify AMI patients precisely. <b><i>Methods:</i></b> This prospective cohort study included 442 patients with suspected non-ST-elevation myocardial infarction in three hospitals in Japan and Taiwan from June 2016 to January 2019. We enrolled patients presenting to the emergency department with symptoms suggestive of AMI and collected blood samples on admission and 1 hour later. Two independent cardiologists centrally adjudicated final diagnoses; all clinical information was reviewed twice: first, using serial hs-cTnT (Roche-Elecsys, primary analysis) and Lumipulse Presto Lumipulse Presto, second, using the Lumipulse Presto hs-cTnI measurements. At first, we compared diagnostic accuracy quantified using receiver operating characteristic (ROC) curves for AMI. Then, we evaluated major adverse cardiovascular events (cardiac death, AMI) in the rule-out group according to a 0-hour/1-hour algorithm at the 30-day follow-up. <b><i>Results:</i></b> Diagnostic accuracy at presentation by the ROC curve for AMI was very high and similar for the LumipulsePresto hs-cTnI and hs-cTnT,(area under the curve [AUC]: LumipulsePresto hs-cTnI, 0.89, 95% confidence interval [CI] 0.86–0.93; hs-cTnT, 0.89, 95% CI 0.85–0.93; <i>p</i> = 0.82). In early presenters, the LumipulsePresto hs-cTnI appeared to maintain the diagnostic performance of hs-cTn for patients with &#x3c;3 h (AUC: LumipulsePresto hs-cTnI, 0.87, 95% CI 0.81–0.92; hs-cTnT, 0.86, 95% CI 0.80–0.92; <i>p</i> = 0.81). The algorithm using the LumipulsePresto hs-cTnI ruled out AMI in 200 patients with negative predictive value and sensitivity of 100% (95% CI 97.3%–100%) and 100% (95% CI 92.7%–100%), respectively, in the rule-out group. <b><i>Conclusion:</i></b> Diagnostic accuracy and clinical utility of the novel LumipulsePresto hs-cTnI assay are high and comparable with the established hs-cTn assays.


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