Validation of High-Sensitivity Troponin I in a 2-Hour Diagnostic Strategy to Assess 30-Day Outcomes in Emergency Department Patients With Possible Acute Coronary Syndrome

Cullen, Louise, Mueller, Christian, Parsonage, William A., Wildi, Karin, Greenslade, Jaimi H., Twerenbold, Raphael, Aldous, Sally, Meller, Bernadette, Tate, Jillian R., Reichlin, Tobias, Hammett, Christopher J., Zellweger, Christa, Ungerer, Jacobus P. J., Gimenez, Maria Rubini, Troughton, Richard, Murray, Karsten, Brown, Anthony F. T., Mueller, Mira, George, Peter, Mosimann, Tamina, Flaws, Dylan F., Reiter, Miriam, Lamanna, Arvin, Haaf, Philip, Pemberton, Christopher J., Richards, A. Mark, Chu, Kevin, Reid, Christopher M., Peacock, William Frank, Jaffe, Allan S., Florkowski, Christopher, Deely, Joanne M. and Than, Martin (2013) Validation of High-Sensitivity Troponin I in a 2-Hour Diagnostic Strategy to Assess 30-Day Outcomes in Emergency Department Patients With Possible Acute Coronary Syndrome. Journal of the American College of Cardiology, 62 14: 1242-1249. doi:10.1016/j.jacc.2013.02.078

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Author Cullen, Louise
Mueller, Christian
Parsonage, William A.
Wildi, Karin
Greenslade, Jaimi H.
Twerenbold, Raphael
Aldous, Sally
Meller, Bernadette
Tate, Jillian R.
Reichlin, Tobias
Hammett, Christopher J.
Zellweger, Christa
Ungerer, Jacobus P. J.
Gimenez, Maria Rubini
Troughton, Richard
Murray, Karsten
Brown, Anthony F. T.
Mueller, Mira
George, Peter
Mosimann, Tamina
Flaws, Dylan F.
Reiter, Miriam
Lamanna, Arvin
Haaf, Philip
Pemberton, Christopher J.
Richards, A. Mark
Chu, Kevin
Reid, Christopher M.
Peacock, William Frank
Jaffe, Allan S.
Florkowski, Christopher
Deely, Joanne M.
Than, Martin
Title Validation of High-Sensitivity Troponin I in a 2-Hour Diagnostic Strategy to Assess 30-Day Outcomes in Emergency Department Patients With Possible Acute Coronary Syndrome
Journal name Journal of the American College of Cardiology   Check publisher's open access policy
ISSN 0735-1097
1558-3597
Publication date 2013-10-01
Sub-type Article (original research)
DOI 10.1016/j.jacc.2013.02.078
Open Access Status Not yet assessed
Volume 62
Issue 14
Start page 1242
End page 1249
Total pages 8
Place of publication San Diego, CA, U.S.A.
Publisher Elsevier Inc.
Language eng
Abstract The study objective was to validate a new high-sensitivity troponin I (hs-TnI) assay in a clinical protocol for assessing patients who present to the emergency department with chest pain.

Protocols using sensitive troponin assays can accelerate the rule out of acute myocardial infarction in patients with low-risk (suspected) acute coronary syndrome (ACS).

This study evaluated 2 prospective cohorts of patients in the emergency department with ACS in an accelerated diagnostic pathway integrating 0- and 2-h hs-TnI results, Thrombolysis In Myocardial Infarction (TIMI) risk scores, and electrocardiography. Strategies to identify low-risk patients incorporated TIMI risk scores= 0 or ≤ 1. The primary endpoint was a major adverse cardiac event (MACE) within 30 days.

In the primary cohort, 1,635 patients were recruited and had 30-day follow-up. A total of 247 patients (15.1%) had a MACE. The finding of no ischemic electrocardiogram and hs-TnI ≤ 26.2 ng/l with the TIMI = 0 and TIMI ≤ 1 pathways, respectively, classified 19.6% (n = 320) and 41.5% (n = 678) of these patients as low risk; 0% (n = 0) and 0.8% (n = 2) had a MACE, respectively. In the secondary cohort, 909 patients were recruited. A total of 156 patients (17.2%) had a MACE. The TIMI = 0 and TIMI ≤ 1 pathways classified 25.3% (n = 230) and 38.6% (n = 351), respectively, of these patients as low risk; 0% (n = 0) and 0.8% (n = 1) had a MACE, respectively. Sensitivity, specificity, and negative predictive value for TIMI = 0 in the primary cohort were 100% (95% confidence interval [CI]: 98.5% to 100%), 23.1% (95% CI: 20.9% to 25.3%), and 100% (95% CI: 98.8% to 100%), respectively. Sensitivity, specificity, and negative predictive value for TIMI ≤ 1 in the primary cohort were 99.2 (95% CI: 97.1 to 99.8), 48.7 (95% CI: 46.1 to 51.3), and 99.7 (95% CI: 98.9 to 99.9), respectively. Sensitivity, specificity, and negative value for TIMI ≤ 1 in the secondary cohort were 99.4% (95% CI: 96.5 to 100), 46.5% (95% CI: 42.9 to 50.1), and 99.7% (95% CI: 98.4 to 100), respectively.

An early-discharge strategy using an hs-TnI assay and TIMI score ≤ 1 had similar safety as previously reported, with the potential to decrease the observation periods and admissions for approximately 40% of patients with suspected ACS. (Advantageous Predictors of Acute Coronary Syndromes Evaluation [APACE] Study, NCT00470587; A 2 hr Accelerated Diagnostic Protocol to Assess patients with chest Pain symptoms using contemporary Troponins as the only biomarker [ADAPT]: a prospective observational validation study, ACTRN12611001069943).
Keyword acute myocardial infarction
Adapt
Apace
chest pain
high-sensitivity troponin I
Timi
Chest-Pain Symptoms
Myocardial-Infarction
Cardiac Troponins
Risk Score
Assay
Protocol
Definitions
Generation
Utility
Trial
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2014 Collection
School of Medicine Publications
 
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