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

• Sponsor: Hennepin Healthcare Research Institute (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04280926
• Collaborator: Siemens Healthineers (Other)
• Enrollment: 1,000
• Location: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 41.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myocardial Infarction; Acute Coronary Syndrome	Diagnostic Test: Cardiac Troponin Testing

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Use of High Sensitivity Cardiac Troponin In Safely Ruling Out Emergency Patients With Acute Myocardial Injury and Infarction (SAFETY)
• Actual Study Start Date: Oct 13, 2020
• Actual Primary Completion Date: Oct 13, 2021
• Anticipated Study Completion Date: Oct 13, 2022

Arms and Interventions

Arm	Intervention/Treatment
Cohort Study population: Prospective, observational cohort study of consecutives patients (goal, 2000 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; Fresh serum or lithium heparin plasma samples will be measured with the Atellica IM TnIH assay (Siemens Heatlhineers).

Outcome Measures

Primary Outcome Measures

1. Incidence of acute myocardial infarction - Abbott hs-cTnI [Day 1]

   Adjudicated diagnosis of acute myocardial injury using the Abbott hs-cTnI assay

2. Incidence of myocardial infarction - Roche Gen 5 cTnT [Day 1]

   Adjudicated diagnosis of acute myocardial injury using the Roche Gen 5 cTnT assay

3. Incidence of myocardial infarction - Abbott contemporary cTnI [Day 1]

   Adjudicated diagnosis of acute myocardial injury using the Abbott contemporary cTnT assay

Secondary Outcome Measures

1. All-cause mortality [up to 180 days]

   any death

2. Cardiac mortality [up to 180 days]

   death due to cardiac reasons

3. Adjudicated index acute myocardial infarction according to 4th UDMI [on admission]

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

4. Number of participants that underwent revascularization [up to 180 days]

   coronary artery bypass graft surgery or percutaneous coronary intervention

5. Safety Outcome - MACE [30 days]

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

6. Safety Outcome - MACE [180 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hennepin Healthcare Research Institute / Hennepin County Medical Center	Minneapolis	Minnesota	United States	55404

Sponsors and Collaborators

• Hennepin Healthcare Research Institute
• Siemens Healthineers

Investigators

• Principal Investigator: Fred S Apple, PhD, Hennepin Healthcare Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hennepin Healthcare Research Institute
• ClinicalTrials.gov Identifier: NCT04280926
• Other Study ID Numbers: SAFETY
• First Posted: Feb 21, 2020
• Last Update Posted: Jan 31, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Hennepin Healthcare Research Institute: Troponin; high-sensitivity cardiac troponin; acute myocardial infarction; Siemens Atellica
• Additional relevant MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; Hypersensitivity; Infarction; Emergencies

Study Results

No Results Posted as of Jan 31, 2022