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

Hennepin Healthcare Research Institute1,000 enrolled

Overview

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.

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

1,000

Conditions

Acute Myocardial Infarction Acute Coronary Syndrome

Interventions

Cardiac Troponin TestingDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hennepin Healthcare Research Institute / Hennepin County Medical Center

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Incidence of acute myocardial infarction - Abbott hs-cTnI

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

Time frame: Day 1

Incidence of myocardial infarction - Roche Gen 5 cTnT

Adjudicated diagnosis of acute myocardial injury using the Roche Gen 5 cTnT assay

Time frame: Day 1

Incidence of myocardial infarction - Abbott contemporary cTnI

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

Time frame: Day 1

Secondary Outcomes

All-cause mortality

any death

Time frame: up to 180 days

Cardiac mortality

death due to cardiac reasons

Time frame: 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

Time frame: on admission

Number of participants that underwent revascularization

coronary artery bypass graft surgery or percutaneous coronary intervention

Time frame: up to 180 days

Safety Outcome - MACE

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

Data from ClinicalTrials.gov

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