scholarly journals Clinical Use of a New High-Sensitivity Cardiac Troponin I Assay in Patients with Suspected Myocardial Infarction

2019 ◽  
Vol 65 (11) ◽  
pp. 1426-1436 ◽  
Author(s):  
Jasper Boeddinghaus ◽  
Raphael Twerenbold ◽  
Thomas Nestelberger ◽  
Luca Koechlin ◽  
Desiree Wussler ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Diagnostic Accuracy ◽  
Cardiac Troponin ◽  
Troponin I ◽  
Clinical Performance ◽  
High Sensitivity ◽  
Primary Objective ◽  
Cardiac Troponin I ◽  
Primary Analysis ◽  
Derivation Cohort

Abstract BACKGROUND We aimed to validate the clinical performance of the high-sensitivity cardiac troponin I [VITROS® Immunodiagnostic Products hs Troponin I (hs-cTnI-VITROS)] assay. METHODS We enrolled patients presenting to the emergency department with symptoms suggestive of acute myocardial infarction (AMI). Final diagnoses were centrally adjudicated by 2 independent cardiologists considering all clinical information, including cardiac imaging: 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-VITROS was measured at presentation and at 1 h in a blinded fashion. The primary objective was direct comparison of diagnostic accuracy as quantified by the area under the ROC curve (AUC) of hs-cTnI-VITROS vs hs-cTnT-Elecsys and hs-cTnI-Architect, and in a subgroup also hs-cTnI-Centaur and hs-cTnI-Access. Secondary objectives included the derivation and validation of an hs-cTnI-VITROS-0/1-h algorithm. RESULTS AMI was the adjudicated final diagnosis in 158 of 1231 (13%) patients. At presentation, the AUC for hs-cTnI-VITROS was 0.95 (95% CI, 0.93–0.96); for hs-cTnT-Elecsys, 0.94 (95% CI, 0.92–0.95); and for hs-cTnI-Architect, 0.92 (95% CI, 0.90–0.94). AUCs for hs-cTnI-Centaur and hs-cTnI-Access were 0.95 (95% CI, 0.94–0.97). Applying the derived hs-cTnI-VITROS-0/1-h algorithm (derivation cohort n = 519) to the validation cohort (n = 520), 53% of patients were ruled out [sensitivity, 100% (95% CI, 94.1–100)] and 14% of patients were ruled in [specificity, 95.6% (95% CI, 93.4–97.2)]. Patients ruled out by the 0/1-h algorithm had a survival rate of 99.8% at 30 days. Findings were confirmed in the secondary analyses using the adjudication including serial measurements of hs-cTnI-Architect. CONCLUSIONS The hs-cTnI-VITROS assay has at least comparable diagnostic accuracy with the currently best validated hs-cTnT and hs-cTnI assays. ClinicalTrials.gov Identifier NCT00470587.

scholarly journals High-Sensitivity Cardiac Troponin I Assay for Early Diagnosis of Acute Myocardial Infarction

2019 ◽  
Vol 65 (7) ◽  
pp. 893-904 ◽  
Author(s):  
Jasper Boeddinghaus ◽  
Thomas Nestelberger ◽  
Raphael Twerenbold ◽  
Luca Koechlin ◽  
Mario Meier ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Diagnostic Accuracy ◽  
Cardiac Troponin ◽  
Troponin I ◽  
High Sensitivity ◽  
Primary Objective ◽  
Cardiac Troponin I ◽  
Primary Analysis ◽  
Derivation Cohort

Abstract BACKGROUND The aim of this study was to validate the clinical performance of the Beckman Access high-sensitivity cardiac troponin I (hs-cTnI) assay. METHODS We enrolled patients presenting to the emergency department with symptoms suggestive of acute myocardial infarction (AMI). Final diagnoses were centrally adjudicated by 2 independent cardiologists with 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 1 h. The primary objective was a direct comparison of diagnostic accuracy as quantified by the area under the ROC curve (AUC) of hs-cTnI Access vs the hs-cTnT Elecsys and hs-cTnI Architect assays. Secondary objectives included the derivation and validation of an hs-cTnI Access-specific 0/1-h algorithm. RESULTS AMI was the adjudicated final diagnosis in 243 of 1579 (15.4%) patients. The AUC at presentation for hs-cTnI Access was 0.95 (95% CI, 0.94–0.96), higher than 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 0/1-h algorithm (derivation cohort n = 686) to the 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 0/1-h algorithm had a survival rate of 100% at 30 days. Findings were confirmed in the secondary analyses by the adjudication including serial measurements of Architect hs-cTnI. CONCLUSIONS Diagnostic accuracy and clinical utility of the Beckman hs-cTnI Access assay are very high and at least comparable to Roche hs-cTnT and Abbott hs-cTnI assays. ClinicalTrials.gov Identifier: NCT00470587.

scholarly journals Clinical Validation of a Novel High-Sensitivity Cardiac Troponin I Assay for Early Diagnosis of Acute Myocardial Infarction

2018 ◽  
Vol 64 (9) ◽  
pp. 1347-1360 ◽  
Author(s):  
Jasper Boeddinghaus ◽  
Raphael Twerenbold ◽  
Thomas Nestelberger ◽  
Patrick Badertscher ◽  
Karin Wildi ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Diagnostic Accuracy ◽  
Cardiac Troponin ◽  
Troponin I ◽  
High Sensitivity ◽  
Primary Objective ◽  
Cardiac Troponin I ◽  
The Novel ◽  
Primary Analysis

Abstract BACKGROUND Clinical performance of the novel high-sensitivity cardiac troponin I (Siemens-hs-cTnI-Centaur) assay is unknown. We aimed to clinically validate the Siemens-hs-cTnI-Centaur assay and develop 0/1-h and 0/2-h algorithms. METHODS We enrolled patients presenting to the emergency department with symptoms suggestive of acute myocardial infarction (AMI). Final diagnoses were centrally adjudicated by 2 independent cardiologists including all clinical information twice: first, using serial hs-cTnT (Roche-Elecsys, primary analysis); second, using hs-cTnI (Abbott-Architect, secondary analysis) measurements in addition to the clinically applied (hs)-cTn. Siemens-hs-cTnI-Centaur was measured at presentation, 1 h, and 2 h. The primary objective was a direct comparison of diagnostic accuracy, quantified by the area under the ROC curve (AUC), of Siemens-hs-cTnI-Centaur vs the 2 established hs-cTn assays (Roche-hs-cTnT-Elecsys, Abbott-hs-cTnI-Architect). Secondary objectives included the development of Siemens-hs-cTnI-Centaur-specific 0/1-h and 0/2-h algorithms. RESULTS AMI was the final diagnosis in 318 of 1755 (18%) patients (using Roche-hs-cTnT-Elecsys for adjudication). The AUC at presentation for Siemens-hs-cTnI-Centaur was 0.94 (95% CI, 0.92–0.96) and comparable with 0.95 (95% CI, 0.93–0.97) for Roche-hs-cTnT-Elecsys and 0.93 (95% CI, 0.90–0.96) for Abbott-hs-cTnI-Architect. Applying the derived Siemens-hs-cTnI-Centaur 0/1-h algorithm to the validation cohort, 46% of patients were ruled out (sensitivity, 99.1%; 95% CI, 95.3–100), and 18% of patients were ruled in (specificity, 94.1%; 95% CI, 91.8–95.9). The Siemens-hs-cTnI-Centaur 0/2-h algorithm ruled out 55% of patients (sensitivity, 100%; 95% CI, 94.1–100), and ruled in 18% of patients (specificity, 96.0%; 95% CI, 93.1–97.9). Findings were confirmed in the secondary analyses using serial measurements of Abbott-hs-cTnI-Architect for adjudication. CONCLUSIONS Diagnostic accuracy and clinical utility of the novel Siemens-hs-cTnI-Centaur assay are high and comparable with the established hs-cTn assays. ClinicalTrials.gov Identifier: NCT00470587

3305Validation of a novel high-sensitivity cardiac troponin i assay for early diagnosis of acute myocardial infarction

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
J Boeddinghaus ◽  
R Twerenbold ◽  
T Nestelberger ◽  
L Koechlin ◽  
D Wussler ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Diagnostic Accuracy ◽  
Cardiac Troponin ◽  
Troponin I ◽  
Clinical Care ◽  
High Sensitivity ◽  
Cardiac Troponin I ◽  
The Novel ◽  
Derivation Cohort

Abstract Background The novel high-sensitivity cardiac troponin I (hs-cTnI)-Vitros assay was developed recently. Before its possible implementation into routine clinical care for triage of chest pain patients, its performance needs clinical validation. Purpose To clinically validate hs-cTnI-Vitros and to derive and validate an assay-specific 0/1h-algorithm following the European Society of Cardiology (ESC) recommendations. Methods In a prospective international multicentre study (12 centres in 5 European countries) 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-Vitros was measured at presentation and at 1h in a blinded fashion. Primary objective was direct comparison of diagnostic accuracy as quantified by the area under the receiver-operating-characteristic curve (AUC) of hs-cTnI-Vitros versus the two established hs-cTn assays (hs-cTnT-Elecsys, hs-cTnI-Architect). Secondary objectives included the derivation and validation of a hs-cTnI-Vitros specific 0/1h-algorithm. Results AMI was the adjudicated final diagnosis in 158/1231 (13%) patients. The AUC at presentation for hs-cTnI-Vitros was 0.95 (95% CI, 0.93–0.96), and significantly higher as hs-cTnT-Elecsys (0.94 [95% CI, 0.92–0.95; p=0.01]) and hs-cTnI-Architect (0.92 [95% CI, 0.90–0.94; p<0.001]). Applying the derived hs-cTnI-Vitros 0/1h-algorithm (derivation cohort n=519) to the validation cohort (n=520), 53% of patients were ruled-out (sensitivity 100% [95% CI, 98.6–100]), and 14% of patients were ruled-in (specificity 95.6% [95% CI, 93.4–97.2]). Patients ruled-out by the 0/1h-algorithm had a survival rate of 99.8% at 30-days and 98.7% at 2-years. Findings were confirmed in the secondary analyses using the adjudication including serial measurements of hs-cTnI (Architect). ROC Curves for the 3 hs-cTn assays at 0h Conclusions The novel hs-cTnI-Vitros assay has even higher diagnostic accuracy as the current gold-standards hs-cTnT and hs-cTnI. The hs-cTnI-Vitros specific 0/1h-algorithms allows a safe rule-out and accurate rule-in of AMI in about 70% of patients within 1h after presentation to the ED. Acknowledgement/Funding Swiss National Science Foundation, the Swiss Heart Foundation, the KTI, the European Union, the Stiftung für kardiovaskuläre Forschung Basel

Potential impact of a novel pathway for suspected myocardial infarction utilising a new high-sensitivity cardiac troponin I assay

2021 ◽  
pp. emermed-2020-210812
Author(s):  
Rob Meek ◽  
Louise Cullen ◽  
Zhong Xian Lu ◽  
Arthur Nasis ◽  
Lisa Kuhn ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Cardiac Troponin ◽  
Troponin I ◽  
Limit Of Detection ◽  
High Sensitivity ◽  
Routine Care ◽  
Primary Objective ◽  
Cardiac Troponin I ◽  
Post Discharge ◽  
Reference Limit

BackgroundHigh-sensitivity cardiac troponin I (hs-cTnI) assays promise high diagnostic accuracy for myocardial infarction (MI). In an ED where conventional cTnI was in use, we evaluated an assessment pathway using the new Access hsTnI assay.MethodsThis retrospective analysis recruited ED patients with suspected MI between June and September 2019. All patients received routine care with a conventional cTnI assay (AccuTnI +3: limit of detection (LoD) 10 ng/L, 99th centile upper reference limit (URL) 40 ng/L, abnormal elevation cut-point 80 ng/L). Arrival, then 90-minute or 360-minute cTnI levels for low and non-low risk patients, respectively (ED Assessment of Chest pain score) guided diagnosis and disposition which was at treating physician discretion. The same patients had arrival and 90-minute or 180-minute samples drawn for hs-cTnI levels (Access hsTnI: LoD 2 ng/L, 99th centile URL 10 ng/L (females) and 20 ng/L (males); abnormal elevation above the URL and delta >30%). Treating physicians were blinded to the hs-cTnI results. Using the hs-cTnI values, investigators retrospectively assigned likely diagnosis, disposition and likelihood of a 30-day major adverse cardiac event (MACE). Admission was recommended for significantly rising hs-cTnI elevations. The primary objective was to demonstrate an acceptable unexpected 30-day post-discharge MACE rate of <1%. cTnI elevation rates, diagnostic outcomes and ED disposition were also compared between pathways.ResultsFor the 935 patients, unexpected 30-day post-discharge MACE rates were 0/935 (0%, 95% CI 0% to 0.4%) with the conventional or novel pathway. For the high-sensitivity and conventional assays, respectively, abnormal elevation rates were 29% (95% CI 26% to 32%) and 19% (95% CI 17% to 22%), for MI were 9% (95% CI 8% to 11%) and 8% (95% CI 6% to 10%), and for hospital admission were 42% (95% CI 39% to 45%) and 43% (95% CI 40% to 47%).ConclusionThe novel pathway using the Access hsTnI assay has an acceptably low 30-day MACE rate.

scholarly journals Clinical Evaluation of a New High-Sensitivity Cardiac Troponin I Assay for Diagnosis and Risk Assessment of Patients with Suspected Acute Myocardial Infarction

Cardiology ◽  
2021 ◽  
pp. 1-7
Author(s):  
Masayuki Shiozaki ◽  
Kenji Inoue ◽  
Satoru Suwa ◽  
Chien-Chang Lee ◽  
Shuo-Ju Chiang ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Diagnostic Accuracy ◽  
Cardiac Troponin ◽  
Troponin I ◽  
Area Under The Curve ◽  
High Sensitivity ◽  
Major Adverse Cardiovascular Events ◽  
Primary Analysis ◽  
Rule Out

<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.

3301A novel high-sensitivity cardiac troponin i assay for early diagnosis of acute myocardial infarction

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
J Boeddinghaus ◽  
T Nestelberger ◽  
R Twerenbold ◽  
L Koechlin ◽  
D Wussler ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Emergency Department ◽  
Diagnostic Accuracy ◽  
Cardiac Troponin ◽  
Troponin I ◽  
High Sensitivity ◽  
Cardiac Troponin I ◽  
The Novel ◽  
Internal Validation

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

scholarly journals The impact of age on the diagnosis of type 1 myocardial infarction using high-sensitivity cardiac troponin

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
M T H Lowry ◽  
D Doudesis ◽  
D Kimenai ◽  
A Anand ◽  
N L Mills
Keyword(s):  
Myocardial Infarction ◽  
Diagnostic Accuracy ◽  
Cardiac Troponin ◽  
Older Patients ◽  
Troponin I ◽  
Age Groups ◽  
High Sensitivity ◽  
Cardiac Troponin I ◽  
Cardiovascular Comorbidities

Abstract Background Cardiac troponin concentrations are influenced by age and comorbidities with values above the 99th centile diagnostic threshold more common in older patients without myocardial infarction. Despite this, rule-in thresholds for myocardial infarction are applied universally regardless of age or comorbidities. Purpose We sought to evaluate how age and cardiovascular comorbidities influence the diagnostic performance of high-sensitivity cardiac troponin I for myocardial infarction. Methods In a secondary analysis of a multi-centre randomised controlled trial, we identified 45,991 consecutive patients with suspected acute coronary syndrome without ST-segment elevation myocardial infarction. The diagnostic performance of high-sensitivity cardiac troponin I measured at presentation for type 1 myocardial infarction was evaluated for the sex-specific 99th centile and thresholds three and five times this value in patients stratified by age (under 50 years, between 50 and 75 years, and over 75 years). The effect of comorbidities on diagnostic accuracy was evaluated using regression modelling. Results Of the 45,991 patients, 8,187 (18%) had myocardial injury of which 7,677 (94%) had a presentation troponin above the sex-specific 99th centile. Mean age of those with myocardial injury was 74 years (range 18–108). The positive predictive value (PPV) of the 99th centile was 54.6% (95% confidence interval [CI] 50.6–58.8%), 58.8% (56.9–60.6%) and 36.6% (35.1–38.2%) in patients under 50 years, between 50 and 75 years, and over 75 years, respectively. Rule-in thresholds three and five-times the 99th centile gave a higher PPV in all age groups with a PPV of 45.5% (43.1–47.8%) and 50.4% (47.6–53.2%), respectively in those aged over 75 years (Table 1). Regardless of threshold, specificity and PPV was lowest in patients over 75 years and decreased with advancing age (Figure 1). Across all age groups, the presence of heart failure resulted in the greatest decrease in PPV (36.9% [34.6–39.2%] versus 50.6% [49.3–51.8%]). Adjusting for cardiovascular comorbidities resulted in modest change in the discrimination of cardiac troponin for myocardial infarction (area under curve 0.89 vs 0.90) and did not prevent a decline in diagnostic accuracy in older patients. Conclusion The specificity and PPV of high-sensitivity cardiac troponin I for myocardial infarction decreases with advancing age. Cardiovascular comorbidities impact the PPV of troponin, but do not explain the decline in diagnostic accuracy with age. Clinicians should be aware of these important differences in performance by age of the diagnostic and rule-in thresholds for myocardial infarction when interpreting troponin results in older patients. FUNDunding Acknowledgement Type of funding sources: Public Institution(s). Main funding source(s): University of Edinburgh Figure 1

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