Acute Coronary Syndrome, Acute Myocardial Infarction
Conditions
Keywords
Troponin, high-sensitivity cardiac troponin, acute myocardial infarction, Siemens Atellica
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTCardiac Troponin Testing
Fresh serum or lithium heparin plasma samples will be measured with the Atellica IM TnIH assay (Siemens Heatlhineers).
Sponsors
Siemens Healthineers
Hennepin Healthcare Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Baseline cTn measurement and at least one additional cTn measurement within 6 hours after initial measurement. 2. At least one 12-lead electrocardiogram
Exclusion criteria
1. Less than 18 years old 2. Pregnancy 3. Trauma 4. Decline to participate 5. Did not present through the ED 6. Transferred from an outside hospital or clinic.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of acute myocardial infarction - Abbott hs-cTnI | Day 1 | Adjudicated diagnosis of acute myocardial injury using the Abbott hs-cTnI assay |
| Incidence of myocardial infarction - Roche Gen 5 cTnT | Day 1 | Adjudicated diagnosis of acute myocardial injury using the Roche Gen 5 cTnT assay |
| Incidence of myocardial infarction - Abbott contemporary cTnI | Day 1 | Adjudicated diagnosis of acute myocardial injury using the Abbott contemporary cTnT assay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants that underwent revascularization | up to 180 days | coronary artery bypass graft surgery or percutaneous coronary intervention |
| Adjudicated index acute myocardial infarction according to 4th UDMI | on admission | acute myocardial infarction, including sub-types following the Fourth Universal Definition of Myocardial Infarction |
| Safety Outcome - MACE | 30 days | Major Adverse Cardiovascular Event - cardiac death, myocardial infarction, revascularization, congestive heart failure |
| All-cause mortality | up to 180 days | any death |
| Cardiac mortality | up to 180 days | death due to cardiac reasons |
Countries
United States
Outcome results
None listed