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Acute Myocardial InfarctionSEIGENCT04772157

Safe Emergency Department DIscharGE Rate (SEIGE)

An observational study of Acute Myocardial Infarction and Acute Coronary Syndrome, run by Hennepin Healthcare Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
Cardiac Troponin Testing
How many people
1,000 participants
Where
1 siteUnited States
Study dates
13 Oct 2020to 13 Oct 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Hennepin Healthcare Research Institute / Hennepin County Medical Center

    Minneapolis, Minnesota, 55404

Other trials in United States

About this study

Official title: 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).

Read the 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.

Being tested
Cardiac Troponin Testing
Keywords
Troponin, acute myocardial injury, acute myocardial infarction, Siemens POC, Siemens POC Atellica® VTLi, Siemens POC HS cTn-I
Medical subject headings
Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiac Troponin TestingDiagnostic test

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

Study groups in NCT04772157
Study groupRoleWhat they receive
CohortStudy 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.
Receives: Diagnostic Test: Cardiac Troponin Testing

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    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.

    Measured: Day 1

  2. Examine Concordance

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

    Measured: Day 1

  3. 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
    2. Limit of detection (LoD)
    3. Concentration threshold tailored to meet a clinical need: Derive an optimal rule-out ng/L cutoff for Siemens POC HS cTn-I Test System.
    4. Accelerated serial sampling (0/2h protocol)
    5. Using the both sex-specific and overall 99th percentiles
    6. Delta (absolute concentration serial change value, 0-2h) analysis

    Measured: Day 1

  4. 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.

    Measured: Day 1

  5. 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.

    Measured: Day 1

Secondary outcomes (4)

  1. All-cause mortality

    any death

    Measured: up to 30 days

  2. Cardiac mortality

    death due to cardiac reasons

    Measured: up to 30 days

  3. Adjudicated index acute myocardial infarction according to 4th UDMI

    acute myocardial infarction, including sub-types following the Fourth Universal Definition of Myocardial Infarction

    Measured: on admission

  4. Safety Outcome - MACE

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

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2021
  2. Study start13 Oct 2020
  3. Primary completion13 Oct 2021
  4. Study completion13 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04772157
Sponsor's protocol ID
SEIGE
Acronym
SEIGE
Status last verified
Oct 2024
First submitted
23 Feb 2021
Last updated
17 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 37131096

  • 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.

    PubMed 36314160

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Myocardial Infarction and Acute Coronary Syndrome, run by Hennepin Healthcare Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04772157, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.

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