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

January 4, 2024 updated by: Hennepin Healthcare Research Institute

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

Active, not recruiting

Conditions

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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
Time Frame: Day 1
Adjudicated diagnosis of acute myocardial injury using the Abbott hs-cTnI assay
Day 1
Incidence of myocardial infarction - Roche Gen 5 cTnT
Time Frame: Day 1
Adjudicated diagnosis of acute myocardial injury using the Roche Gen 5 cTnT assay
Day 1
Incidence of myocardial infarction - Abbott contemporary cTnI
Time Frame: Day 1
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
Time Frame: up to 180 days
any death
up to 180 days
Cardiac mortality
Time Frame: up to 180 days
death due to cardiac reasons
up to 180 days
Adjudicated index acute myocardial infarction according to 4th UDMI
Time Frame: on admission
acute myocardial infarction, including sub-types following the Fourth Universal Definition of Myocardial Infarction
on admission
Number of participants that underwent revascularization
Time Frame: up to 180 days
coronary artery bypass graft surgery or percutaneous coronary intervention
up to 180 days
Safety Outcome - MACE
Time Frame: 30 days
Major Adverse Cardiovascular Event - cardiac death, myocardial infarction, revascularization, congestive heart failure
30 days
Safety Outcome - MACE
Time Frame: 180 days
Major Adverse Cardiovascular Event - cardiac death, myocardial infarction, revascularization, congestive heart failure
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hennepin Healthcare Research Institute

Collaborators

Siemens Healthineers

Investigators

  • Principal Investigator: Fred S Apple, PhD, Hennepin Healthcare Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2020

Primary Completion (Actual)

October 13, 2021

Study Completion (Estimated)

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 (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAFETY

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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