Safe Emergency Department DIscharGE Rate (SEIGE)

NCT04772157 | Completed DMC FDA Device

• 1 other identifier: SEIGE
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Acute Myocardial Infarction; Acute Coronary Syndrome

Keywords

Troponin; acute myocardial injury; acute myocardial infarction; Siemens POC; Siemens POC Atellica® VTLi; Siemens POC HS cTn-I

Outcome Measures

Primary Outcomes (5)

• 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: 1. Single measurement strategies 1. Limit of detection (LoD) 2. Concentration threshold tailored to meet a clinical need: Derive an optimal rule-out ng/L cutoff for Siemens POC HS cTn-I Test System. 2. Accelerated serial sampling (0/2h protocol) 1. Using the both sex-specific and overall 99th percentiles 2. Delta (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 Outcomes (4)

• All-cause mortality

  up to 30 days

• Cardiac mortality

  up to 30 days

• Adjudicated index acute myocardial infarction according to 4th UDMI

  on admission

• Safety Outcome - MACE

  30 days

Study Arms (1)

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

Interventions

Cardiac Troponin Testing DIAGNOSTIC_TEST

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

Cohort

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead
• Siemens Healthineers: collaborator

Study Sites (1)

Hennepin Healthcare Research Institute / Hennepin County Medical Center

Minneapolis, Minnesota, 55404, United States

Location

Related Publications (2)

• Neumann JT, Twerenbold R, Ojeda F, Aldous SJ, Allen BR, Apple FS, Babel H, Christenson RH, Cullen L, Di Carluccio E, Doudesis D, Ekelund U, Giannitsis E, Greenslade J, Inoue K, Jernberg T, Kavsak P, Keller T, Lee KK, Lindahl B, Lorenz T, Mahler SA, Mills NL, Mokhtari A, Parsonage W, Pickering JW, Pemberton CJ, Reich C, Richards AM, Sandoval Y, Than MP, Toprak B, Troughton RW, Worster A, Zeller T, Ziegler A, Blankenberg S; ARTEMIS study group. Personalized diagnosis in suspected myocardial infarction. Clin Res Cardiol. 2023 Sep;112(9):1288-1301. doi: 10.1007/s00392-023-02206-3. Epub 2023 May 2.

  PMID: 37131096 DERIVED

• Apple FS, Smith SW, Greenslade JH, Sandoval Y, Parsonage W, Ranasinghe I, Gaikwad N, Schulz K, Stephensen L, Schmidt CW, Okeson B, Cullen L; SAMIE Investigators. Single High-Sensitivity Point-of-Care Whole-Blood Cardiac Troponin I Measurement to Rule Out Acute Myocardial Infarction at Low Risk. Circulation. 2022 Dec 20;146(25):1918-1929. doi: 10.1161/CIRCULATIONAHA.122.061148. Epub 2022 Oct 31.

  PMID: 36314160 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood and plasma tested on the Siemens POC HS cTn-I Analyzer

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Fred S Apple, PhD

  Hennepin Healthcare Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: February 26, 2021
• Study Start: October 13, 2020
• Primary Completion: October 13, 2021
• Study Completion: October 13, 2024
• Last Updated: December 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)