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Completed

NCT Number: NCT04772157

Safe Emergency Department DIscharGE Rate (SEIGE)

The Siemens POC High Sensitivity Troponin-I Test System is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I (cTn-I) in fresh human capillary (fingerstick) whole blood, and lithium-heparinized venous whole blood or plasma, to be used by healthcare professionals at the point of care (POC) as well as in the clinical laboratory.

The Siemens POC High Sensitivity Troponin-I Test System is to be used as an aid in the diagnosis of myocardial infarction (MI).

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Key information

Conditions

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

Age range

21 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

Study purpose/objective:

  • Evaluate the clinical performance of the Siemens POC HS cTn-I test system for the diagnosis and rule out of AMI in patients presenting to the emergency department in whom serial cTnI measurements are obtained on clinical indication.
  • Correlate the blood and plasma outcomes on the Siemens POC HS cTn-I test system as function of the corresponding hematocrit (Hct) values.

Hypothesis: The Siemens POC HS cTn-I Test System 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

  • Presents to the ED, or ambulatory care center equivalent, with signs or symptoms suspicious of a possible ACS event.
  • Baseline cTn-I measurement and one additional cTn-I measurement at two hours after the first measurement.
  • At least one 12-lead electrocardiogram

Exclusion criteria

  • Less than 21 years old
  • Pregnancy
  • Trauma
  • Declines to participate or has indicated that their blood/ medical information cannot be used for investigational purposes
  • Did not present through the ED
  • Transferred from an outside hospital or clinic.

Treatment and study plan

Cardiac Troponin Testing

Diagnostic Test

Lithium heparin whole blood and plasma samples will be measured with Siemens POC High Sensitivity Troponin-I Test System.

Primary outcomes

  1. Examine the incidence of undetectable(<LoD), measurable (LoD - 99th percentile), and increased (>99th percentile) cTn concentrations for the Siemens POC HS cTn-I Test System

    Time frame: Day 1

    Examine the incidence of undetectable(<LoD), measurable (LoD - 99th percentile), and increased (>99th percentile) cTn concentrations for the Siemens POC HS cTn-I Test System in comparison to a high sensitivity cTnI assay (Abbott & Siemens Healthineers) to determine the potential impact on positivity rate, defined by sex-specific 99th percentiles.

  2. Examine Concordance

    Time frame: Day 1

    Examine concordance (dis) between hs-cTnI in comparison to a high sensitivity (Abbott & Siemens Healthineers) cTnI assay

  3. Examine the diagnostic performance for acute myocardial injury and acute myocardial infarction

    Time frame: Day 1

    Examine the diagnostic performance for a) acute myocardial injury and b) acute myocardial infarction based on various diagnostic strategies using hs-cTnI measurement(s), as follows:

    • Single measurement strategies
    • Limit of detection (LoD)
    • Concentration threshold tailored to meet a clinical need: Derive an optimal rule-out ng/L cutoff for Siemens POC HS cTn-I Test System.
    • Accelerated serial sampling (0/2h protocol)
    • Using the both sex-specific and overall 99th percentiles
    • Delta (absolute concentration serial change value, 0-2h) analysis

  4. Describe the incidence, clinical characteristics and outcomes of patients with and without hs-cTnI increases above the sex-specific 99th percentile URLs

    Time frame: Day 1

    Describe the incidence, clinical characteristics and outcomes of patients with and without hs-cTnI increases above the sex-specific 99th percentile URLs, including patients categorized with acute myocardial injury and acute myocardial infarction, including type 1 and 2 myocardial infarction following the 4th Universal Definition of Myocardial Infarction.

  5. Impact on the incidence of myocardial injury and myocardial infarction diagnoses.

    Time frame: Day 1

    Examine the potential impact on the incidence of myocardial injury and myocardial infarction diagnoses using hs-cTnI upon clinical practice implementation with a comparison to the hospital's final ICD-10 code diagnosis of type 1 and type 2 MIs.

Secondary outcomes

  1. All-cause mortality

    Time frame: up to 30 days

    any death

  2. Cardiac mortality

    Time frame: up to 30 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. Safety Outcome - MACE

    Time frame: 30 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

Evaluation of the Siemens POC HS CTn-I Test System

Acronym: SEIGE

Important dates

Study start
2020
Primary completion
2021
Study completion
2024
First posted
Feb 26, 2021
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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