scholarly journals Randomised controlled trial of the Limit of Detection of Troponin and ECG Discharge (LoDED) strategy versus usual care in adult patients with chest pain attending the emergency department: study protocol

BMJ Open ◽  
2018 ◽  
Vol 8 (10) ◽  
pp. e025339 ◽  
Author(s):  
Edward Carlton ◽  
Sarah Campbell ◽  
Jenny Ingram ◽  
Rebecca Kandiyali ◽  
Hazel Taylor ◽  
...  
Keyword(s):  
Emergency Department ◽  
Chest Pain ◽  
Randomised Controlled Trial ◽  
Limit Of Detection ◽  
Controlled Trial ◽  
High Sensitivity ◽  
Early Discharge ◽  
High Sensitivity Troponin ◽  
Randomised Controlled ◽  
Rule Out

IntroductionObservational data suggest a single high-sensitivity troponin blood test taken at emergency department (ED) presentation could be used to rule out major adverse cardiac events (MACE) in 10%–60% of ED patients with chest pain. This is done using an ‘undetectable’ cut-off (the Limit of Detection: LoD). We combined the LoD cut-off with ECG findings to create the LoDED strategy. We aim to establish whether the LoDED strategy works under real-life conditions, when compared with existing strategies, in a way that is cost-effective and acceptable to patients.Methods and analysisThis is a parallel-group pragmatic randomised controlled trial across UK EDs. Adults presenting to ED with suspected cardiac chest pain will be randomised 1:1. Existing rule-out strategies in current use across study centres, using serial high-sensitivity troponin testing, will be compared with the LoDED strategy. The primary outcome is successful early discharge (discharge from hospital within 4 hours of arrival) without MACE occurring within 30 days. Secondary outcomes include initial length of hospital stay; comparative costs; patient satisfaction and acceptability to patients. To detect a 9% difference between the early discharge rates (assuming an 8% rate in the standard care group) with 90% power, 594 patients need to be recruited, assuming a 95% follow-up rate.Ethics and disseminationThe study has been approved by the Frenchay Research Ethics Committee (reference 18/SW/0038). Results will be published in an international peer-reviewed journal. Lay summaries will be made available to patients.Trial registration numberISRCTN86184521; Pre-results.

scholarly journals Limit of detection of troponin discharge strategy versus usual care: randomised controlled trial

Heart ◽  
2020 ◽  
Vol 106 (20) ◽  
pp. 1586-1594 ◽  
Author(s):  
Edward Watts Carlton ◽  
Jenny Ingram ◽  
Hazel Taylor ◽  
Joel Glynn ◽  
Rebecca Kandiyali ◽  
...  
Keyword(s):  
Chest Pain ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Limit Of Detection ◽  
Controlled Trial ◽  
High Sensitivity ◽  
Clinical Effectiveness ◽  
Coronary Syndrome ◽  
Randomised Controlled ◽  
Rule Out

IntroductionThe clinical effectiveness of a ‘rule-out’ acute coronary syndrome (ACS) strategy for emergency department patients with chest pain, incorporating a single undetectable high-sensitivity cardiac troponin (hs-cTn) taken at presentation, together with a non-ischaemic ECG, remains unknown.MethodsA randomised controlled trial, across eight hospitals in the UK, aimed to establish the clinical effectiveness of an undetectable hs-cTn and ECG (limit of detection and ECG discharge (LoDED)) discharge strategy. Eligible adult patients presented with chest pain; the treating clinician intended to perform investigations to rule out an ACS; the initial ECG was non-ischaemic; and peak symptoms occurred <6 hours previously. Participants were randomised 1:1 to either the LoDED strategy or the usual rule-out strategy. The primary outcome was discharge from the hospital within 4 hours of arrival, without a major adverse cardiac event (MACE) within 30 days.ResultsBetween June 2018 and March 2019, 632 patients were randomised; 3 were later withdrawn. Of 629 patients (age 53.8 (SD 16.1) years, 41% women), 7% had a MACE within 30 days. For the LoDED strategy, 141 of 309 (46%) patients were discharged within 4 hours, without MACE within 30 days, and for usual care, 114 of 311 (37%); pooled adjusted OR 1.58 (95% CI 0.84 to 2.98). No patient with an initial undetectable hs-cTn had a MACE within 30 days.ConclusionThe LoDED strategy facilitates safe early discharge in >40% of patients with chest pain. Clinical effectiveness is variable when compared with existing rule-out strategies and influenced by wider system factors.Trial registration numberISRCTN86184521.

scholarly journals LO61: Test characteristics of high sensitivity troponin T performed at emergency department arrival for acute myocardial infarction in patients with reduced kidney function

CJEM ◽  
2018 ◽  
Vol 20 (S1) ◽  
pp. S28-S28
Author(s):  
A. D. McRae ◽  
S. Vatanpour ◽  
J. Ji ◽  
H. Yang ◽  
D. Southern ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Emergency Department ◽  
Chest Pain ◽  
Troponin T ◽  
High Sensitivity ◽  
Test Characteristics ◽  
High Sensitivity Troponin ◽  
High Sensitivity Troponin T ◽  
Rule Out

Introduction: Patients with chronic kidney disease (CKD) are at high risk of cardiovascular events, and have worse outcomes following acute myocardial infarction (AMI). Cardiac troponin is often elevated in CKD, making the diagnosis of AMI challenging in this population. We sought to quantify test characteristics for AMI of a high-sensitivity troponin T (hsTnT) assay performed at emergency department (ED) arrival in CKD patients with chest pain, and to derive rule-out cutoffs specific to patient subgroups stratified by estimated glomerular filtration rate (eGFR). We also quantified the sensitivity and classification performance of the assays limit of detection (5 ng/L) and the FDA-approved limit of quantitation (6 ng/L) for ruling out AMI at ED arrival. Methods: Consecutive patients in four urban EDs from the 2013 calendar year with suspected cardiac chest pain who had a Roche Elecsys hsTnT assay performed on arrival were included f. This analysis was restricted to patients with an eGFR< 60 ml/min/1.73m2. The primary outcome was 7-day AMI. Secondary outcomes included major adverse cardiac events (death, AMI and revascularization). Test characteristics were calculated and ROC curves were generated for eGFR subgroups. Results: 1416 patients were included. 7-day AMI incidence was 10.1%. 73% of patients had an initial hsTnT concentration greater than the assays 99th percentile (14 ng/L). TCurrently accepted cutoffs to rule out MI at ED arrival ( 5 ng/L and 6 ng/L) had 100% sensitivity for AMI, but no patients with an eGFR less than 30 ml/min/1.73M had hsTnT concentrations below these thresholds. We derived eGFR-adjusted cutoffs to rule out MI with sensitivity >98% at ED arrival, which were able to rule out 6-42% of patients, depending on eGFR category. The proportion of patients able to be accurately ruled-in with a single hsTnT assay was substantially lower among patients with an eGFR <30 ml/min/1.73m2 (6-20% vs 25-43%). We also derived eGFR-adjusted cutoffs to rule-in AMI with specificity >90%, which accurately ruled-in up to 18% of patients. Conclusion: Cutoffs achieving acceptable diagnostic performance for AMI using single hsTnT sampling on ED arrival may have limited clinical utility, particularly among patients with very low eGFR. The ideal diagnostic strategy for AMI in patients with CKD likely involves serial high-sensitivity troponin testing with diagnostic thresholds customized to different eGFR categories.

scholarly journals LO10: Low high-sensitivity troponin concentrations identify low-risk chest pain patients unlikely to benefit from further risk stratification

CJEM ◽  
2020 ◽  
Vol 22 (S1) ◽  
pp. S10-S10
Author(s):  
J. Andruchow ◽  
T. Boyne ◽  
G. Innes ◽  
S. Vatanpour ◽  
I. Seiden-Long ◽  
...  
Keyword(s):  
Chest Pain ◽  
Risk Stratification ◽  
Symptom Onset ◽  
Limit Of Detection ◽  
Troponin T ◽  
High Sensitivity ◽  
Low Risk ◽  
High Sensitivity Troponin ◽  
Pain Patients ◽  
Rule Out

Introduction: Very low high-sensitivity troponin-T (hs-cTnT) concentrations on presentation can rule out acute myocardial infarction (AMI), but the ability to identify patients at low risk of 30-day major adverse cardiac events (MACE) is less clear. This study examines the sensitivity of low concentrations of hs-cTnT on presentation to rule out 30-day MACE. Methods: This prospective cohort study enrolled emergency department chest pain patients with non-ischemic ECGs who underwent AMI rule-out with an hs-cTnT assay. The primary outcome was 30-day MACE; secondary outcomes were individual MACE components. Because guidelines recommend using a single hs-cTnT strategy only for patients with more than 3-hours since symptom onset, a subgroup analysis was performed for this population. Outcomes were adjudicated based on review of medical records and telephone follow-up. Results: Of 1,167 patients enrolled, 125 (10.7%) experienced 30-day MACE and 97 (8.3%) suffered AMI on the index visit. More than one-third (35.6%) had presenting hs-cTnT concentrations below the limit of detection (5ng/L), which was 94.4% (95%CI 88.8-97.7%) sensitive for 30-day MACE and 99.0% (95%CI 94.5-100%) sensitive for index AMI. Of 292 (25.0%) patients with hs-cTnT < 5ng/L and at least 3-hours since symptom onset, only 3 experienced 30-day MACE (sensitivity 97.6%, 95%CI 93.2-100%) and none suffered AMI within 30-days (sensitivity 100%, 95%CI 96.3-100%). Conclusion: Among patients with non-ischemic ECGs and >3-hours since symptom onset, low hs-cTnT concentrations on presentation confer a very low risk of 30-day MACE. In the absence of a high risk clinical presentation, further risk stratification is likely to be low yield.

scholarly journals Adding stress biomarkers to high sensitivity troponin measurements increases precision and efficacy of rapid rule out protocols for NSTEMI

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
I Restan ◽  
O.T Steiro ◽  
H.L Tjora ◽  
J Langoergen ◽  
T Omland ◽  
...  
Keyword(s):  
Chest Pain ◽  
Acute Chest Pain ◽  
High Sensitivity ◽  
Final Diagnosis ◽  
Public Institution ◽  
P Value ◽  
Funding Source ◽  
University Hospitals ◽  
High Sensitivity Troponin ◽  
Rule Out

Abstract Background NSTEMI may be ruled out in patients presenting with acute chest pain based on low baseline high sensitivity troponin (cTn) at admission. This procedure is limited by a low expected frequency of ruled out non-cardiac chest pain (NCCP) patients. Purpose To investigate if stress-induced biomarkers (glucose or copeptin) combined with cTn can increase the rate of NCCP ruled out without an unacceptable increase in incorrectly ruled out NSTEMI. Method 971 patients with suspected NSTE-ACS were included. Final diagnosis was adjudicated by two independent cardiologists using clinical data including routine cTnT. Additionally, baseline cTnI, cTnI from Singulex Clarity System (cTnI(sgx)), copeptin and glucose were measured. Diagnostic performance to rule out NSTEMI was compared between the ESC rule out algorithms for cTnT and cTnI(Abbott), a local cTnI(sgx) algorithm and different combinations of cTn with copeptin or glucose Results Median age 61 years, 60% male. 13% had NSTEMI, 12% had UAP and 60% NCCP. Distribution of copeptin and glucose concentrations (NSTEMI and NCCP) is shown in figure 1. Copeptin and cTnT produces an algorithm with lower miss rate for NSTEMI, increased rule out rate for NCCP and significantly higher AUC (DeLong test, p value &lt;0.001) compared to the ESC algorithm (Table 1). cTnI(sgx) and copeptin showed higher rule out for NCCP and higher AUC (p value &lt;0.001), however an increased rule out rate for NSTEMIs. Combining cTnI(Abbott) and glucose gave a similar miss rate for NSTEMI as ESC, but increased rule out rate for NCCP and higher AUC (p value &lt;0.001). Conclusion Combining cTnT or cTnI(sgx) with copeptin; or cTnI with glucose, improves diagnostic precision and efficacy of rule out protocols for NSTEMI in patients presenting with acute chest pain. Figure 1 Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): Western Norway Regional Health Authority; Haukeland and Stavanger University Hospitals

scholarly journals Postcard intervention for repeat self-harm: randomised controlled trial

2010 ◽  
Vol 197 (1) ◽  
pp. 55-60 ◽  
Author(s):  
Annette L. Beautrais ◽  
Sheree J. Gibb ◽  
Alan Faulkner ◽  
David M. Fergusson ◽  
Roger T. Mulder
Keyword(s):  
Emergency Department ◽  
New Zealand ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Suicidal Behaviour ◽  
Controlled Trial ◽  
Elevated Risk ◽  
Emergency Department Presentation ◽  
Self Harm ◽  
Randomised Controlled

BackgroundSelf-harm and suicidal behaviour are common reasons for emergency department presentation. Those who present with self-harm have an elevated risk of further suicidal behaviour and death.AimsTo examine whether a postcard intervention reduces self-harm re-presentations in individuals presenting to the emergency department.MethodRandomised controlled trial conducted in Christchurch, New Zealand. The intervention consisted of six postcards mailed during the 12 months following an index emergency department attendance for self-harm. Outcome measures were the proportion of participants re-presenting with self-harm and the number of re-presentations for self-harm in the 12 months following the initial presentation.ResultsAfter adjustment for prior self-harm, there were no significant differences between the control and intervention groups in the proportion of participants re-presenting with self-harm or in the total number of re-presentations for self-harm.ConclusionsThe postcard intervention did not reduce further self-harm. Together with previous results this finding suggests that the postcard intervention may be effective only for selected subgroups.

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