Clinical trial NCT04772157: Safe Emergency Department DIscharGE Rate (SEIGE)
Official title: Evaluation of the Siemens POC HS CTn-I Test System
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
Collaborators: name: Siemens Healthineers
First posted: 2021-02-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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.

Eligibility criteria: 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.

Primary outcomes:
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
timeFrame: Day 1
measure: Examine Concordance
timeFrame: Day 1
measure: Examine the diagnostic performance for acute myocardial injury and acute myocardial infarction
timeFrame: Day 1
measure: Describe the incidence, clinical characteristics and outcomes of patients with and without hs-cTnI increases above the sex-specific 99th percentile URLs
timeFrame: Day 1
measure: Impact on the incidence of myocardial injury and myocardial infarction diagnoses.
timeFrame: Day 1
Secondary outcomes:
measure: All-cause mortality
timeFrame: up to 30 days
measure: Cardiac mortality
timeFrame: up to 30 days
measure: Adjudicated index acute myocardial infarction according to 4th UDMI
timeFrame: on admission
measure: Safety Outcome - MACE
timeFrame: 30 days
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin Healthcare Research Institute / Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: Hennepin Healthcare Research Institute
name: Fred S Apple, PhD
role: PRINCIPAL_INVESTIGATOR
References: