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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome; Acute Myocardial Infarction
• Intervention / Treatment: Diagnostic test: Cardiac Troponin Testing

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.

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Hennepin Healthcare Research Institute / Hennepin County Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Cardiac Troponin Testing; Fresh serum or lithium heparin plasma samples will be measured with the Atellica IM TnIH assay (Siemens Heatlhineers).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	any death	up to 180 days
Cardiac mortality	death due to cardiac reasons	up to 180 days
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

Collaborators and Investigators

• Sponsor: Hennepin Healthcare Research Institute
• Collaborators: Siemens Healthineers
• Investigators: Principal Investigator: Fred S Apple, PhD, Hennepin Healthcare Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2020
• Primary Completion (Actual): October 13, 2021
• Study Completion (Actual): October 13, 2024

Study Registration Dates

• First Submitted: January 23, 2020
• First Submitted That Met QC Criteria: February 20, 2020
• First Posted (Actual): February 21, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: acute myocardial infarction; Troponin; high-sensitivity cardiac troponin; Siemens Atellica
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Immune System Diseases; Necrosis; Myocardial Ischemia; Ischemia; Hypersensitivity; Myocardial Infarction; Infarction; Acute Coronary Syndrome
• Other Study ID Numbers: SAFETY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No