Rapid Rule-Out of Myocardial Infarction After 30 Minutes as an Alternative to 1 Hour: The RACING-MI Cohort Study.

STUDY OBJECTIVE: The aim of this study was to investigate whether myocardial infarction can be safely ruled in or out after 30 minutes as an alternative to 1 hour. METHODS: This was a prospective, single-center clinical study enrolling patients admitted to the emergency department. Patients with chest pain suggestive of myocardial infarction were eligible for inclusion. There was no walk-in to the emergency department, and patients with highly elevated out-of-hospital troponin were transferred directly to an invasive heart center. High-sensitivity troponin I was measured at admission (0 hour), 30 minutes, 1 hour, and 3 hours. Diagnostic performance was assessed using the sensitivity and negative predictive value (primary endpoints) as measures of ability to rule out myocardial infarction. Specificity and positive predictive value of myocardial infarction were used as measures for the ability to rule in myocardial infarction (secondary endpoints). RESULTS: In total, 1,003 patients qualified for analysis. Median age was 64 (interquartile range 52 to 74) years, and 42% were women. Myocardial infarction was confirmed in 9% of patients. In the validation cohort (n=503), the 0-h/30-min algorithm assigned 242 (48%) patients to rule out, 54 (11%) to rule in, and 207 (41%) to the observational zone. This resulted in a sensitivity of 100% (92.0% to 100%), negative predictive value of 100% (95% confidence interval 98.5% to 100%), specificity of 96.7% (94.7% to 98.2%), and positive predictive value of 72.2% (58.4% to 83.5%). In comparison, the 0-h/1-h algorithm performed with a sensitivity of 100% (92.0% to 100%), negative predictive value of 100% (98.5% to 100%), specificity of 97.2% (95.2% to 98.5%), and positive predictive value of 75.5% (61.7% to 86.2%). CONCLUSION: The accelerated 0-h/30-min algorithm allowed for safe rule-out of myocardial infarction 30 minutes after admission. The rule-in ability of the 0-h/30-min algorithm was comparable to that of the 0-h/1h algorithm.

Single troponin measurement to rule-out acute myocardial infarction in early presenters.

BACKGROUND: A single high-sensitive cardiac troponin (hs-cTn) can be used to rule-out acute myocardial infarction (MI) in patients presenting >3 hours (3 h) after chest pain onset to the emergency department. This study aimed to investigate the safety of ruling-out MI in early presenters with chest pain ≤3 h using a single hs-cTnI at admission. METHODS: We prospectively enrolled patients presenting with chest pain suggestive of MI. Hs-cTnI (Siemens ADVIA Centaur TNIH, Limit of detection: 2.2 ng/L) was measured at admission. Two physicians adjudicated final diagnosis. A diagnostic cut-off value <3 ng/L was used to rule-out MI. Patients were classified as early (chest pain ≤3 h) or late presenters (>3 h). RESULTS: We included 1370 patients with available admission hs-cTnI results: median (Q1-Q3) age 65 (52-74), female sex: 43%, previous MI: 22%. We confirmed MI in 118 (8.6%) patients. Overall, 470 (34%) patients were classified as early, 770 (56%) as late presenters, and 130 (9%) patients had unknown onset. When applying the diagnostic cut-off value, MI was correctly ruled-out at admission in 370 (27%) patients: 134 (29%) early presenters, 206 (27%) late presenters and 30 (23%) patients with unknown onset. This resulted in an overall negative predictive value of 100% (95% CI: 99.0-100%), with both 100% (97.3-100%) for early and 100% (98.2-100%) for late presenters, respectively. Sensitivity was similarly high in the two groups. CONCLUSION: MI could be safely ruled-out in all patients presenting with chest pain ≤3 h when using a single hs-cTnI value <3 ng/L as diagnostic cut-off. TRIAL REGISTRATION NUMBER: NCT03634384.

External validation of a high-sensitive troponin I algorithm for rapid evaluation of acute myocardial infarction in a Danish cohort.

AIMS: An accelerated diagnostic algorithm for ruling-in or ruling-out myocardial infarction (MI) after 1 hour (1 h) has recently been derived and internally validated for the Siemens ADVIA Centaur TNIH assay. We aimed to validate the diagnostic performance of the TNIH 0 h/1 h algorithm ad modum Boeddinghaus in a Danish cohort. METHODS AND RESULTS: Patients with chest pain suggestive of MI were prospectively enrolled. High-sensitive troponin I (TNIH) was measured at admission (0 h) and after 30 minutes (30 m), 1 h, and 3 hours (3 h). We externally validated the TNIH 0 h/1 h algorithm ad modum Boeddinghaus in Danish patients. Moreover, we applied the algorithm using the second TNIH measurement at 30 m instead of 1 h. We enrolled 1003 patients: median (Q1-Q3) age 64 (52-74) years, 42% female, and 23% with previous MI. Myocardial infarction was the final diagnosis in 9% of patients. Median (Q1-Q3) times from admission to 30 m and 1 h blood draw were 35 min (30-37 min) and 67 min (62-75 min), respectively. Using the 0 h and 1 h results, 468 (47%) patients were assigned to rule-out, 104 (10%) to rule-in, and 431 (43%) to the observational zone. This resulted in a negative predictive value of 100% (95% confidence interval: 99.2-100%), sensitivity of 100% (95.9-100%), positive predictive value of 79.8 (70.8-87.0%), and specificity of 97.7% (96.5-98.6%). The diagnostic performance after 30 m was similar. CONCLUSIONS: The TNIH 0 h/1 h algorithm ad modum Boeddinghaus performed excellently for rule-out of MI in a Danish cohort. The Boeddinghaus algorithm also performed excellently after only 30 m. TRIAL REGISTRATION NUMBER: NCT03634384. TRIAL REGISTRY NAME AND URL: Rapid Use of High-Sensitive Cardiac Troponin I for Ruling-in and Ruling-out Acute Myocardial Infarction (RACING-MI), https://clinicaltrials.gov/ct2/show/NCT03634384.

Trends in antidiabetic drug utilization and expenditure in Denmark: A 22-year nationwide study.

AIMS: To examine the nationwide trends in antidiabetic drug utilization and expenditure in Denmark over the past 22 years. METHODS: Data on antidiabetic use and expenditure from 1996 to 2017 were retrieved from the Register of Medicinal Product Statistics. Antidiabetic drug use is reported as defined daily dose (DDD) in total counts and per 1000 inhabitants/d. Expenditure is reported as volume sold in total counts per 1000 inhabitants and as annual mean expenditure. RESULTS: Throughout the study period, the total use of antidiabetic drugs increased from 16.4 to 55.8 DDDs per 1000 inhabitants/d, while total expenditure increased from €59 to €286 m. The introduction of glucagon-like peptide-1 receptor agonists (GLP-1RAs), dipeptidyl peptidase-4 inhibitors and sodium-glucose co-transporter-2 inhibitors has, since 2005, led to considerable variation in the proportional use of the different drug classes. Use of insulin and insulin analogues accounted for the majority of the cost of antidiabetic drugs, peaking at 75% in 2008; however, its proportional impact on overall antidiabetic drug expenditure decreased to ~44% in 2017. In contrast, a steep increase in GLP-1RA expenditure was observed from 2010 to 2017, reaching an annual cost of €85 m (~29% of all antidiabetic expenditure). CONCLUSION: Antidiabetic drug utilization and cost in Denmark has increased considerably over the last 22 years, in accordance with the increased incidence of type 2 diabetes and changes in treatment guidelines. The release of several novel antidiabetic drugs seems to be responsible for the increase in antidiabetic drug expenditure.

Basic life support training: Demonstration versus lecture - A randomised controlled trial.

INTRODUCTION: Basic life support (BLS) and the use of an automated external defibrillator (AED) improve survival from cardiac arrest. The gold standard for teaching BLS/AED is yet to be identified. The aim of this study was to compare the learning outcome of an instructor-led demonstration with a formal lecture for introducing BLS/AED skills. We hypothesized that a demonstration was superior to a lecture. METHODS: First year-medical students were randomised to either a demonstration or a lecture using PowerPoint® Presentation for skill introduction during European Resuscitation Council BLS/AED courses. Participants were skill-tested after training and required to perform all skills correctly to pass the test. Finally, all participants were asked to state their preferred teaching method. RESULTS: Overall, 247 participants were included in the analysis (demonstration group: 124, lecture group: 123). Pass rate was 63% in both groups, p = 1.00. Both groups performed median compression rates within guidelines recommendations, p = 0.09. Mean compression depth was 55 mm (10 mm) in the demonstration group compared with 52 mm (10 mm) in the lecture group, p = 0.05. Median tidal volume was 265 (192, 447) ml and 405 (262, 578) ml, p < 0.001, respectively. The lecture group was 3 s faster at initiating BLS, p < 0.001. In total, 226 (91%) participants preferred demonstration on a manikin for introducing BLS/AED. CONCLUSION: There was no statistically significant difference in pass rate when comparing a demonstration with a lecture for introducing BLS/AED. The lecture group was slightly faster at initiating BLS. Most participants preferred a demonstration as introduction.

Certified Basic Life Support Instructors Identify Improper Cardiopulmonary Resuscitation Skills Poorly: Instructor Assessments Versus Resuscitation Manikin Data.

INTRODUCTION: During basic life support (BLS) training, instructors assess learners' cardiopulmonary resuscitation (CPR) skills and correct errors to ensure high-quality performance. This study aimed to investigate certified BLS instructors' assessments of CPR skills. METHODS: Data were collected at BLS courses for medical students at Aarhus University, Aarhus, Denmark. Two certified BLS instructors evaluated each learner with a cardiac arrest test scenario, where learners demonstrated CPR on a resuscitation manikin for 3.5 minutes. Instructors' assessments were compared with manikin data as reference for correct performance. The first 3 CPR cycles were analyzed. Correct chest compressions were defined as 2 or more of 3 CPR cycles with 30 ± 2 chest compressions, 50 to 60 mm depth, and 100 to 120 min rate. Correct rescue breaths were defined as 50% or more efficient breaths with visible, but not excessive manikin chest inflation (for instructors) or 500 to 600mL air (manikin data). RESULTS: Overall, 90 CPR assessments were performed by 16 instructor pairs. Instructors passed 81 (90%) learners, whereas manikin pass rate was 2%. Instructors identified correct chest compressions with a sensitivity of 0.96 [95% confidence interval (CI) = 0.79-1) and a specificity of 0.05 (95% CI = 0.01-0.14), as well as correct rescue breaths with a sensitivity of 1 (95% CI = 0.40-1) and a specificity of 0.07 (95% CI = 0.03-0.15). Instructors mistakenly failed 1 learner with adequate chest compression depth, while passing 53 (59%) learners with improper depth. Moreover, 80 (89%) improper rescue breath performances were not identified. CONCLUSIONS: Certified BLS instructors assess CPR skills poorly. Particularly, improper chest compression depth and rescue breaths are not identified.

Rapid use of high-sensitive cardiac troponin I for ruling-in and ruling-out of acute myocardial infarction (RACING-MI): study protocol.

Introduction: The European Society of Cardiology has suggested an accelerated algorithm for ruling-in and ruling-out myocardial infarction (MI) with high-sensitive cardiac troponin (hs-cTn) measured at admission (0 hour) and after 1 hour (1 hour) as an alternative to standard measurements at 0 hour and 3 hours. However, the 0 hour/1 hour algorithm has only been tested in a limited amount of patient cohorts and not for all hs-cTn assays. Moreover, it is unknown if MI can be ruled-out faster than 1 hour. In this single-centre, clinical trial, we will investigate whether MI safely can be ruled-in or ruled-out after 30 min and 1 hour. Methods and analysis: Patients with chest pain suggestive of MI admitted to the emergency department will be subjected to hs-cTn measurements at the following time points: 0 hour, 30 min, 1 hour and 3 hours. Chest pain characteristics will be recorded. In total, 1000 patients with all four blood samples will be included. The diagnostic algorithms will be derived based on the first 500 patients and validated in the subsequent 500 patients. The primary endpoint is the negative predictive value of the 0 hour/30 min and the 0 hour/1 hour algorithms. Secondary endpoints include positive predictive value, sensitivity and specificity. Results will be compared with the standard 0 hour/3 hour algorithm. Ethics and dissemination: Oral and written informed consent will be obtained from all patients. The trial is approved by The Regional Committee on Health Research Ethics and the Danish Data Protection Agency. Data will be disseminated and submitted to peer-reviewed scientific journals and meetings irrespective of study outcome. Trial registration number: NCT03634384.