Safe Emergency Department dIscharGE Rate (SEIGE)

Acute Coronary Syndrome Clinical Trial

— SEIGE  

Official title:

Evaluation of the Siemens POC HS cTn-I Test System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04772157
• Other study ID #: SEIGE
• Status: Active, not recruiting
• Start date: October 13, 2020
• Est. completion date: October 13, 2024

Study information

• Verified date: January 2024
• Source: Hennepin Healthcare Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 (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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: October 13, 2024
• Est. primary completion date: October 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
United States	Hennepin Healthcare Research Institute / Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Hennepin Healthcare Research Institute	Siemens Healthineers

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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(	Day 1
Primary	Examine Concordance	Examine concordance (dis) between hs-cTnI in comparison to a high sensitivity (Abbott & Siemens Healthineers) cTnI assay	Day 1
Primary	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 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	Day 1
Primary	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
Primary	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	All-cause mortality	any death	up to 30 days
Secondary	Cardiac mortality	death due to cardiac reasons	up to 30 days
Secondary	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
Secondary	Safety Outcome - MACE	Major Adverse Cardiovascular Event - cardiac death, myocardial infarction, revascularization, congestive heart failure	30 days