Use of High Sensitivity Cardiac Troponin In Ruling Out Emergency Patients With Acute Myocardial Injury and Infarction

Study Overview
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Brief Summary
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Examine the analytical and clinical performance of Atellica IM TnIH assay for the diagnosis and rule out of acute myocardial injury and myocardial infarction in patients presenting to the emergency department in whom serial cTnI measurements are obtained on clinical indication.

Detailed Description
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Background: Studies addressing the clinical performance of the Siemens Healthineers High-Sensitivity Troponin I assay (TnIH) on the Atellica IM analyzer for the diagnosis and rule out of acute myocardial injury and myocardial infarction in consecutive patients presenting to a United States (US) emergency department are lacking. Study objective: Examine the analytical and clinical performance of Atellica IM TnIH assay for the diagnosis and rule out of acute myocardial injury and myocardial infarction in patients presenting to the emergency department in whom serial cTnI measurements are obtained on clinical indication. Hypothesis: The Atellica IM TnIH assay will offer an excellent diagnostic performance for acute myocardial injury and acute myocardial infarction, as well as expedite the risk stratification of patients for early discharge from the emergency department.

Official Title
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Use of High Sensitivity Cardiac Troponin In Safely Ruling Out Emergency Patients With Acute Myocardial Injury and Infarction (SAFETY)

Conditions
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Acute Myocardial Infarction, Acute Coronary Syndrome

Intervention / Treatment
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* Diagnostic Test: Cardiac Troponin Testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Baseline cTn measurement and at least one additional cTn measurement within 6 hours after initial measurement. At least one 12-lead electrocardiogram Exclusion Criteria: Less than 18 years old Pregnancy Trauma Decline to participate Did not present through the ED Transferred from an outside hospital or clinic.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort<br>Study population: Prospective, observational cohort study of consecutives patients (goal, 2000 patients over 4 months) presenting to the emergency department, in whom serial cTnI measurements are ordered on clinical indication at Hennepin Healthcare / Hennepin County Medical Center (Minneapolis, MN, USA) to rule-in and rule-out acute myocardial infarction. | Diagnostic Test: Cardiac Troponin Testing<br>* Fresh serum or lithium heparin plasma samples will be measured with the Atellica IM TnIH assay (Siemens Heatlhineers).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute myocardial infarction - Abbott hs-cTnI | Adjudicated diagnosis of acute myocardial injury using the Abbott hs-cTnI assay | Day 1 | 
| Incidence of myocardial infarction - Roche Gen 5 cTnT | Adjudicated diagnosis of acute myocardial injury using the Roche Gen 5 cTnT assay | Day 1 | 
| Incidence of myocardial infarction - Abbott contemporary cTnI | Adjudicated diagnosis of acute myocardial injury using the Abbott contemporary cTnT assay | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | any death | up to 180 days | 
| Cardiac mortality | death due to cardiac reasons | up to 180 days | 
| Adjudicated index acute myocardial infarction according to 4th UDMI | acute myocardial infarction, including sub-types following the Fourth Universal Definition of Myocardial Infarction | on admission | 
| Number of participants that underwent revascularization | coronary artery bypass graft surgery or percutaneous coronary intervention | up to 180 days | 
| Safety Outcome - MACE | Major Adverse Cardiovascular Event - cardiac death, myocardial infarction, revascularization, congestive heart failure | 30 days | 
| Safety Outcome - MACE | Major Adverse Cardiovascular Event - cardiac death, myocardial infarction, revascularization, congestive heart failure | 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Troponin, high-sensitivity cardiac troponin, acute myocardial infarction, Siemens Atellica