Use of High Sensitivity Cardiac Troponin in Ruling Out Emergency Patients with Acute Myocardial Injury and Infarction
- Conditions
- Acute Coronary SyndromeAcute Myocardial Infarction
- Interventions
- Diagnostic Test: Cardiac Troponin Testing
- Registration Number
- NCT04280926
- Lead Sponsor
- Hennepin Healthcare Research Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1000
- Baseline cTn measurement and at least one additional cTn measurement within 6 hours after initial measurement.
- At least one 12-lead electrocardiogram
- Less than 18 years old
- Pregnancy
- Trauma
- Decline to participate
- Did not present through the ED
- Transferred from an outside hospital or clinic.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort Cardiac Troponin Testing 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Number of participants that underwent revascularization up to 180 days coronary artery bypass graft surgery or percutaneous coronary intervention
All-cause mortality up to 180 days any death
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 180 days Major Adverse Cardiovascular Event - cardiac death, myocardial infarction, revascularization, congestive heart failure
Cardiac mortality up to 180 days death due to cardiac reasons
Trial Locations
- Locations (1)
Hennepin Healthcare Research Institute / Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States