Use of High Sensitivity Cardiac Troponin in Ruling Out Emergency Patients with Acute Myocardial Injury and Infarction (SAFETY)

Hennepin Healthcare

Status: Completed

Conditions: Acute Coronary Syndrome; Acute Myocardial Infarction

Treatments: Diagnostic Test: Cardiac Troponin Testing

Study type: Observational

Funder types: Other

Identifiers

NCT04280926

SAFETY

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,000 participants in 1 patient group

Cohort

Description:

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.

Treatment:

Diagnostic Test: Cardiac Troponin Testing