Acute Myocardial InfarctionSAFETYNCT04280926
Use of High Sensitivity Cardiac Troponin In Ruling Out Emergency Patients With Acute Myocardial Injury and Infarction
An observational study of Acute Myocardial Infarction and Acute Coronary Syndrome, run by Fred Apple at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction, Acute Coronary Syndrome
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Baseline cTn measurement and at least one additional cTn measurement within 6 hours after initial measurement.
- At least one 12-lead electrocardiogram
Who cannot join
- Less than 18 years old
- Pregnancy
- Trauma
- Decline to participate
- 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
About this study
Official title: Use of High Sensitivity Cardiac Troponin In Safely Ruling Out Emergency Patients With Acute Myocardial Injury and Infarction (SAFETY)
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.
Read the 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.
- Being tested
- Cardiac Troponin Testing
- Keywords
- Troponin, high-sensitivity cardiac troponin, acute myocardial infarction, Siemens Atellica
- 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
Fresh serum or lithium heparin plasma samples will be measured with the Atellica IM TnIH assay (Siemens Heatlhineers).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Cardiac Troponin Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute myocardial infarction - Abbott hs-cTnI
Adjudicated diagnosis of acute myocardial injury using the Abbott hs-cTnI assay
Measured: Day 1
Incidence of myocardial infarction - Roche Gen 5 cTnT
Adjudicated diagnosis of acute myocardial injury using the Roche Gen 5 cTnT assay
Measured: Day 1
Incidence of myocardial infarction - Abbott contemporary cTnI
Adjudicated diagnosis of acute myocardial injury using the Abbott contemporary cTnT assay
Measured: Day 1
Secondary outcomes (6)
All-cause mortality
any death
Measured: up to 180 days
Cardiac mortality
death due to cardiac reasons
Measured: up to 180 days
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
Number of participants that underwent revascularization
coronary artery bypass graft surgery or percutaneous coronary intervention
Measured: up to 180 days
Safety Outcome - MACE
Major Adverse Cardiovascular Event - cardiac death, myocardial infarction, revascularization, congestive heart failure
Measured: 30 days
Safety Outcome - MACE
Major Adverse Cardiovascular Event - cardiac death, myocardial infarction, revascularization, congestive heart failure
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start13 Oct 2020
- Primary completion13 Oct 2021
- Study completion13 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fred Apple
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fred Apple, Hennepin Healthcare Research Institute
- Investigators
- Fred S Apple, PhD, Principal investigator, Hennepin Healthcare Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280926
- Sponsor's protocol ID
- SAFETY
- Acronym
- SAFETY
- Status last verified
- Oct 2026
- First submitted
- 23 Jan 2020
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Fabre-Estremera B, Smith SW, Sandoval Y, Schulz K, Okeson B, Cullen L, Apple FS. Rapid Rule-Out of Myocardial Infarction Using a Single High-Sensitivity Cardiac Troponin I Measurement Strategy at Presentation to the Emergency Department: The SAFETY Study. Clin Chem. 2023 Jun 1;69(6):627-636. doi: 10.1093/clinchem/hvad033.
PubMed 37022774
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of High Sensitivity Cardiac Troponin In Safely Ruling Out Emergency Patients With Acute Myocardial Injury and Infarction (SAFETY)
- ClinicalTrials.gov ID
- NCT04280926
- Acronym / sponsor ID
- SAFETY / SAFETY
- Keywords
- Troponin, high-sensitivity cardiac troponin, acute myocardial infarction, Siemens Atellica
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Fred AppleUniversity, hospital or other
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 13 Oct 2021 (actual)
- Study completion
- 13 Oct 2024 (actual)
- First posted
- 21 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Diagnostic Test: Cardiac Troponin TestingStudy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Baseline cTn measurement and at least one additional cTn measurement within 6 hours after initial measurement.
- At least one 12-lead electrocardiogram
Key exclusion criteria (6 listed)
- Less than 18 years old
- Pregnancy
- Trauma
- Decline to participate
- Did not present through the ED
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Troponin TestingFresh serum or lithium heparin plasma samples will be measured with the Atellica IM TnIH assay (Siemens Heatlhineers). | Diagnostic test | Cohort |
Primary outcome
Incidence of acute myocardial infarction - Abbott hs-cTnI
Time frame: Day 1
Adjudicated diagnosis of acute myocardial injury using the Abbott hs-cTnI assay
Incidence of myocardial infarction - Roche Gen 5 cTnT
Time frame: Day 1
Adjudicated diagnosis of acute myocardial injury using the Roche Gen 5 cTnT assay
Incidence of myocardial infarction - Abbott contemporary cTnI
Time frame: Day 1
Adjudicated diagnosis of acute myocardial injury using the Abbott contemporary cTnT assay
6 secondary outcomes
All-cause mortality
Time frame: up to 180 days
Cardiac mortality
Time frame: up to 180 days
Adjudicated index acute myocardial infarction according to 4th UDMI
Time frame: on admission
Number of participants that underwent revascularization
Time frame: up to 180 days
Safety Outcome - MACE
Time frame: 30 days
Safety Outcome - MACE
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Derived from this study: PubMed 37022774Fabre-Estremera B, Smith SW, Sandoval Y, Schulz K, Okeson B, Cullen L, Apple FS. Rapid Rule-Out of Myocardial Infarction Using a Single High-Sensitivity Cardiac Troponin I Measurement Strategy at Presentation to the Emergency Department: The SAFETY Study. Clin Chem. 2023 Jun 1;69(6):627-636. doi: 10.1093/clinchem/hvad033.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fred S Apple, PhD principal investigator
Hennepin Healthcare Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction and Acute Coronary Syndrome, run by Fred Apple 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 2 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 15 Oct 2026. 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?
Incidence of acute myocardial infarction - Abbott hs-cTnI (time frame: Day 1). The study lists 3 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 NCT04280926, which also lists 1 linked publication.
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 15 Oct 2026.