Use of High Sensitivity Cardiac Troponin In Ruling Out Emergency Patients With Acute Myocardial Injury and Infarction

Acute Coronary Syndrome Clinical Trial

— SAFETY  

Official title:

Use of High Sensitivity Cardiac Troponin In Safely Ruling Out Emergency Patients With Acute Myocardial Injury and Infarction (SAFETY)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04280926
• Other study ID #: SAFETY
• 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

Examine the analytical and clinical performance of Atellica IM TnIH assay for the diagnosis and rule out of acute myocardial injury and myocardial infarction in patients presenting to the emergency department in whom serial cTnI measurements are obtained on clinical indication.

Description:

Background: Studies addressing the clinical performance of the Siemens Healthineers High-Sensitivity Troponin I assay (TnIH) on the Atellica IM analyzer for the diagnosis and rule out of acute myocardial injury and myocardial infarction in consecutive patients presenting to a United States (US) emergency department are lacking.

Study objective: Examine the analytical and clinical performance of Atellica IM TnIH assay for the diagnosis and rule out of acute myocardial injury and myocardial infarction in patients presenting to the emergency department in whom serial cTnI measurements are obtained on clinical indication.

Hypothesis: The Atellica IM TnIH assay 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: 18 Years and older

Eligibility

Inclusion Criteria:

1. Baseline cTn measurement and at least one additional cTn measurement within 6 hours after initial measurement.

2. At least one 12-lead electrocardiogram

Exclusion Criteria:

1. Less than 18 years old

2. Pregnancy

3. Trauma

4. Decline to participate

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
• Emergencies
• Hypersensitivity
• Infarction
• Myocardial Infarction

Intervention

Diagnostic Test:
• Cardiac Troponin Testing
Fresh serum or lithium heparin plasma samples will be measured with the Atellica IM TnIH assay (Siemens Heatlhineers).

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	Incidence of acute myocardial infarction - Abbott hs-cTnI	Adjudicated diagnosis of acute myocardial injury using the Abbott hs-cTnI assay	Day 1
Primary	Incidence of myocardial infarction - Roche Gen 5 cTnT	Adjudicated diagnosis of acute myocardial injury using the Roche Gen 5 cTnT assay	Day 1
Primary	Incidence of myocardial infarction - Abbott contemporary cTnI	Adjudicated diagnosis of acute myocardial injury using the Abbott contemporary cTnT assay	Day 1
Secondary	All-cause mortality	any death	up to 180 days
Secondary	Cardiac mortality	death due to cardiac reasons	up to 180 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	Number of participants that underwent revascularization	coronary artery bypass graft surgery or percutaneous coronary intervention	up to 180 days
Secondary	Safety Outcome - MACE	Major Adverse Cardiovascular Event - cardiac death, myocardial infarction, revascularization, congestive heart failure	30 days
Secondary	Safety Outcome - MACE	Major Adverse Cardiovascular Event - cardiac death, myocardial infarction, revascularization, congestive heart failure	180 days