Clinical trial NCT04280926: Use of High Sensitivity Cardiac Troponin in Ruling Out Emergency Patients with Acute Myocardial Injury and Infarction
Official title: Use of High Sensitivity Cardiac Troponin in Safely Ruling Out Emergency Patients with Acute Myocardial Injury and Infarction (SAFETY)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Acute Coronary Syndrome
Keywords: Troponin
high-sensitivity cardiac troponin
acute myocardial infarction
Siemens Atellica
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
Collaborators: name: Siemens Healthineers
First posted: 2020-02-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of acute myocardial infarction - Abbott hs-cTnI
timeFrame: Day 1
measure: Incidence of myocardial infarction - Roche Gen 5 cTnT
timeFrame: Day 1
measure: Incidence of myocardial infarction - Abbott contemporary cTnI
timeFrame: Day 1
Secondary outcomes:
measure: All-cause mortality
timeFrame: up to 180 days
measure: Cardiac mortality
timeFrame: up to 180 days
measure: Adjudicated index acute myocardial infarction according to 4th UDMI
timeFrame: on admission
measure: Number of participants that underwent revascularization
timeFrame: up to 180 days
measure: Safety Outcome - MACE
timeFrame: 30 days
measure: Safety Outcome - MACE
timeFrame: 180 days
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin Healthcare Research Institute / Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: Hennepin Healthcare Research Institute
name: Fred S Apple, PhD
role: PRINCIPAL_INVESTIGATOR
References: