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NCT Number: NCT04280926

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

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.

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Key information

Conditions

Acute Myocardial Infarction Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hennepin Healthcare Research Institute / Hennepin County Medical Center

Minneapolis, Minnesota, 55404, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Baseline cTn measurement and at least one additional cTn measurement within 6 hours after initial measurement.
  • At least one 12-lead electrocardiogram

Exclusion criteria

  • Less than 18 years old
  • Pregnancy
  • Trauma
  • Decline to participate
  • Did not present through the ED
  • Transferred from an outside hospital or clinic.

Treatment and study plan

Cardiac Troponin Testing

Diagnostic Test

Fresh serum or lithium heparin plasma samples will be measured with the Atellica IM TnIH assay (Siemens Heatlhineers).

Primary outcomes

  1. Incidence of acute myocardial infarction - Abbott hs-cTnI

    Time frame: Day 1

    Adjudicated diagnosis of acute myocardial injury using the Abbott hs-cTnI assay

  2. 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

  3. Incidence of myocardial infarction - Abbott contemporary cTnI

    Time frame: Day 1

    Adjudicated diagnosis of acute myocardial injury using the Abbott contemporary cTnT assay

Secondary outcomes

  1. All-cause mortality

    Time frame: up to 180 days

    any death

  2. Cardiac mortality

    Time frame: up to 180 days

    death due to cardiac reasons

  3. 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

  4. Number of participants that underwent revascularization

    Time frame: up to 180 days

    coronary artery bypass graft surgery or percutaneous coronary intervention

  5. Safety Outcome - MACE

    Time frame: 30 days

    Major Adverse Cardiovascular Event - cardiac death, myocardial infarction, revascularization, congestive heart failure

  6. Safety Outcome - MACE

    Time frame: 180 days

    Major Adverse Cardiovascular Event - cardiac death, myocardial infarction, revascularization, congestive heart failure

Sponsors and collaborators

Lead sponsor

Hennepin Healthcare Research Institute

Other

Collaborators

  • Siemens Healthineers

Registry information

Official study title

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

Acronym: SAFETY

Important dates

Study start
2020
Primary completion
2021
Study completion
2024
First posted
Feb 21, 2020
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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