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| Name | Class |
|---|---|
| Siemens Healthineers | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Troponin Testing | Diagnostic Test | Fresh serum or lithium heparin plasma samples will be measured with the Atellica IM TnIH assay (Siemens Heatlhineers). |
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | any death | up to 180 days |
| Cardiac mortality | death due to cardiac reasons | up to 180 days |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Fred S Apple, PhD | Hennepin Healthcare Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hennepin Healthcare Research Institute / Hennepin County Medical Center | Minneapolis | Minnesota | 55404 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37022774 | Derived | Fabre-Estremera B, Smith SW, Sandoval Y, Schulz K, Okeson B, Cullen L, Apple FS. Rapid Rule-Out of Myocardial Infarction Using a Single High-Sensitivity Cardiac Troponin I Measurement Strategy at Presentation to the Emergency Department: The SAFETY Study. Clin Chem. 2023 Jun 1;69(6):627-636. doi: 10.1093/clinchem/hvad033. |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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Excess blood is biobanked after clinical testing for cTnI
| 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 |