Safe Emergency Department dIscharGE Rate (SEIGE) (SEIGE)

Evaluation of the Siemens POC HS cTn-I Test System

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Coronary Syndrome; Acute Myocardial Infarction
• Intervention / Treatment: Diagnostic test: Cardiac Troponin Testing

Detailed Description

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.

• 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: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients (goal, 1000 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. Presents to the ED, or ambulatory care center equivalent, with signs or symptoms suspicious of a possible ACS event.
2. Baseline cTn-I measurement and one additional cTn-I measurement at two hours after the first measurement.
3. At least one 12-lead electrocardiogram

Exclusion Criteria

1. Less than 21 years old
2. Pregnancy
3. Trauma
4. Declines to participate or has indicated that their blood/ medical information cannot be used for investigational purposes
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, 1000 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; Lithium heparin whole blood and plasma samples will be measured with Siemens POC High Sensitivity Troponin-I Test System.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Day 1
Examine Concordance	Examine concordance (dis) between hs-cTnI in comparison to a high sensitivity (Abbott & Siemens Healthineers) cTnI assay	Day 1
Examine the diagnostic performance for acute myocardial injury and acute myocardial infarction	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 strategiesLimit 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 percentilesDelta (absolute concentration serial change value, 0-2h) analysis	Day 1
Describe the incidence, clinical characteristics and outcomes of patients with and without hs-cTnI increases above the sex-specific 99th percentile URLs	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.	Day 1
Impact on the incidence of myocardial injury and myocardial infarction diagnoses.	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.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Safety Outcome - MACE	Major Adverse Cardiovascular Event - cardiac death, myocardial infarction, revascularization, congestive heart failure	30 days
All-cause mortality	any death	up to 30 days
Cardiac mortality	death due to cardiac reasons	up to 30 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 (Estimated): October 13, 2024

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: February 23, 2021
• First Posted (Actual): February 26, 2021

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: acute myocardial infarction; Troponin; acute myocardial injury; Siemens POC; Siemens POC Atellica® VTLi; Siemens POC HS cTn-I
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Acute Coronary Syndrome
• Other Study ID Numbers: SEIGE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes