Non-ST Elevation Myocardial InfarctionOUT-ACSNCT02983123
One-hour Troponin in a Low-prevalence Population of Acute Coronary Syndrome
An observational study of Non-ST Elevation Myocardial Infarction and Acute Coronary Syndrome, run by Oslo University Hospital at 1 site in Norway.
Trial summary
This study aims to evaluate if the 1-hour rule-in/rule-out algorithm for a high-sensitivity cardiac troponin T (hs-cTnT) is safe and effective for use in the primary care where the patients have a lower pretest probability of an acute myocardial infarction (MI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-ST Elevation Myocardial Infarction, Acute Coronary Syndrome, Angina, Unstable
- What is being tested?
- 1-hour hs-cTnT
- Type of treatment
- Surgery or procedure
- How many people
- 1,750 participants
- Where
- 1 siteNorway
- Study dates
- 15 Nov 2016to 22 Oct 2018
- 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: Patients presenting to the Oslo Accident and Emergency Outpatient Clinic with symptoms suggestive of a benign non-cardiac chest pain, who needs further pre-hospital testing at the Observation Unit for a safe rule-out of an acute MI.
Who may be able to join
- Patients at the outpatient clinic with suspected non-cardiac chest pain/symptoms who need further testing for a safe rule-out of an acute MI
- Written informed consent
Who cannot join
- Acute STEMI (ST-elevation myocardial infarction) (directly to the hospital)
- Strong suspicion of an acute NSTEMI/unstable angina (directly to the hospital)
- Terminal kidney disease with a glomerular filtration rate (GFR) < 30
- Unable to communicate in Norwegian, Swedish, Danish or English language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Introduction of an 1-hour Algorithm for High-sensitivity Cardiac-specific Troponin T for Faster Assessment of NSTEMI in a Low-prevalence Population at Oslo Accident and Emergency Outpatient Clinic
This study aims to evaluate if the 1-hour rule-in/rule-out algorithm for a high-sensitivity cardiac troponin T (hs-cTnT) is safe and effective for use in the primary care where the patients have a lower pretest probability of an acute myocardial infarction (MI). During this study troponins will be collected at 0-, 1- and 4/6-hours, where absolute changes in the values will decide whether the patient need hospitalization or not.
Read the detailed description
Many patients seek Oslo Accident and Emergency Outpatient Clinic (OAEOC) with chest pain. The majority of these patients have symptoms suggestive of a benign non-cardiac chest pain. These patients do not need a directly transfer to the hospital, but can be admitted to the Observation Unit at the OAEOC for further pre-hospital testing, including serial troponins for a safe rule-out of acute MI. The main goal of this study is to improve the current routine at the Observation Unit at OAEOC by introducing the 1-hour algorithm for hs-cTnT for a faster rule-in/rule-out of acute MI.
All recruited patients will have serial troponins drawn at 0, 1- and 4/6 hours, with the main hypothesis that the absolute changes within 1 hour can be used as surrogates for the changes and conclusions drawn after 4/6 hours. The cut-off levels used within the 0/1-hour algorithm are assay specific as specified in the 2015 European Society of Cardiology Guidelines for the management of acute NSTEMI.
- Conditions
- Non-ST Elevation Myocardial Infarction, Acute Coronary Syndrome, Angina, Unstable, NSTEMI - Non-ST Segment Elevation MI
- Being tested
- 1-hour hs-cTnT
- Keywords
- Acute MI, Acute myocardial infarction cardiac troponin, High-sensitivity cardiac troponin T, 0/1-hour algorithm, Outpatient clinic, Cardiac troponin, Chest pain
- Medical subject headings
- Non-ST Elevated Myocardial Infarction, Acute Coronary Syndrome, Angina, Unstable, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-hour hs-cTnTProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 hour-troponin | 1-hour troponin collected of all recruited patients in addition to the daily routine with serial troponins collected at 0- and 4/6 hours. Receives: Procedure: 1-hour hs-cTnT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients transferred to the hospital (rule-in) according to the 1-hour algorithm
The troponin tests will be sent to the laboratory for analysis every 4th hour. The tests are analyzed in 1-2 hours.
Measured: 7-10 hours
Number of patients without significant changes (rule-out) according to the 1-hour algorithm
The troponin tests will be sent to the laboratory for analysis every 4th hour. The tests are analyzed in 1-2 hours.
Measured: 7-10 hours
Secondary outcomes (4)
Number of patients with significant change in the 3rd troponin (drawn after 4-6 hours) who were not identified by the 1-hour algorithm
Measured: 10 hours
Significant changes between the first and second ECG?
Measured: 6 hours
Number of patients with NSTEMI admitted to the hospital from the Observation Unit at the OAEOC
The final diagnosis will be collected from all patients who were admitted to the hospital from the Observation Unit during the study
Measured: 1 week
90 days follow-up of all recruited patients
How many will have an acute MI the next 3 months?
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study start15 Nov 2016
- Primary completion22 Oct 2018
- Study completion22 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Non-ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- 1,750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Dan Atar, Oslo University Hospital
- Investigators
- Dan Atar, MD, PhD, Study director, Oslo University Hospital and University of Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983123
- Sponsor's protocol ID
- 2016/1241/REK
- Other IDs
- 2016/13308, 2016
- Acronym
- OUT-ACS
- Status last verified
- Mar 2019
- First submitted
- 29 Nov 2016
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Johannessen TR, Melessen IMB, Vallersnes OM, Manten A, Halvorsen S, Atar D, Harskamp RE. Adequately identifying low-risk chest pain in emergency primary care: evaluating the performance of preHEAR(T) based on two European cohorts. Open Heart. 2025 Jul 27;12(2):e003362. doi: 10.1136/openhrt-2025-003362.
PubMed 40716792Johannessen TR, Halvorsen S, Atar D, Vallersnes OM. Performance of the Novel Observation Group Criteria of the European Society of Cardiology (ESC) 0/1-Hour Algorithm in a Low-Risk Population. J Am Heart Assoc. 2022 Apr 5;11(7):e024927. doi: 10.1161/JAHA.121.024927. Epub 2022 Mar 30. No abstract available.
PubMed 35352564Johannessen TR, Atar D, Vallersnes OM, Larstorp ACK, Mdala I, Halvorsen S. Comparison of a single high-sensitivity cardiac troponin T measurement with the HEART score for rapid rule-out of acute myocardial infarction in a primary care emergency setting: a cohort study. BMJ Open. 2021 Feb 24;11(2):e046024. doi: 10.1136/bmjopen-2020-046024.
PubMed 33627355Johannessen TR, Vallersnes OM, Halvorsen S, Larstorp ACK, Mdala I, Atar D. Pre-hospital One-Hour Troponin in a Low-Prevalence Population of Acute Coronary Syndrome: OUT-ACS study. Open Heart. 2020 Jul;7(2):e001296. doi: 10.1136/openhrt-2020-001296.
PubMed 32719074
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introduction of an 1-hour Algorithm for High-sensitivity Cardiac-specific Troponin T for Faster Assessment of NSTEMI in a Low-prevalence Population at Oslo Accident and Emergency Outpatient Clinic
- ClinicalTrials.gov ID
- NCT02983123
- Acronym / sponsor ID
- OUT-ACS / 2016/1241/REK
- Conditions
- Non-ST Elevation Myocardial Infarction, Acute Coronary Syndrome, Angina, Unstable, NSTEMI - Non-ST Segment Elevation MI
- Keywords
- Acute MI, Acute myocardial infarction cardiac troponin, High-sensitivity cardiac troponin T, 0/1-hour algorithm, Outpatient clinic, Cardiac troponin, Chest pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,750 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- 22 Oct 2018 (actual)
- Study completion
- 22 Oct 2018 (actual)
- First posted
- 6 Dec 2016 (estimated)
- 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.
This study aims to evaluate if the 1-hour rule-in/rule-out algorithm for a high-sensitivity cardiac troponin T (hs-cTnT) is safe and effective for use in the primary care where the patients have a lower pretest probability of an acute myocardial infarction (MI). During this study troponins will be collected at 0-, 1- and 4/6-hours, where absolute changes in the values will decide whether the patient need hospitalization or not.
Detailed description
Many patients seek Oslo Accident and Emergency Outpatient Clinic (OAEOC) with chest pain. The majority of these patients have symptoms suggestive of a benign non-cardiac chest pain. These patients do not need a directly transfer to the hospital, but can be admitted to the Observation Unit at the OAEOC for further pre-hospital testing, including serial troponins for a safe rule-out of acute MI. The main goal of this study is to improve the current routine at the Observation Unit at OAEOC by introducing the 1-hour algorithm for hs-cTnT for a faster rule-in/rule-out of acute MI.
All recruited patients will have serial troponins drawn at 0, 1- and 4/6 hours, with the main hypothesis that the absolute changes within 1 hour can be used as surrogates for the changes and conclusions drawn after 4/6 hours. The cut-off levels used within the 0/1-hour algorithm are assay specific as specified in the 2015 European Society of Cardiology Guidelines for the management of acute NSTEMI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 hour-troponin | – | Procedure: 1-hour hs-cTnT1-hour troponin collected of all recruited patients in addition to the daily routine with serial troponins collected at 0- and 4/6 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the Oslo Accident and Emergency Outpatient Clinic with symptoms suggestive of a benign non-cardiac chest pain, who needs further pre-hospital testing at the Observation Unit for a safe rule-out of an acute MI.
Key inclusion criteria (2 listed)
- Patients at the outpatient clinic with suspected non-cardiac chest pain/symptoms who need further testing for a safe rule-out of an acute MI
- Written informed consent
Key exclusion criteria (4 listed)
- Acute STEMI (ST-elevation myocardial infarction) (directly to the hospital)
- Strong suspicion of an acute NSTEMI/unstable angina (directly to the hospital)
- Terminal kidney disease with a glomerular filtration rate (GFR) < 30
- Unable to communicate in Norwegian, Swedish, Danish or English language
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 |
|---|---|---|
| 1-hour hs-cTnT | Procedure or surgery | 1 hour-troponin |
Primary outcome
Number of patients transferred to the hospital (rule-in) according to the 1-hour algorithm
Time frame: 7-10 hours
The troponin tests will be sent to the laboratory for analysis every 4th hour. The tests are analyzed in 1-2 hours.
Number of patients without significant changes (rule-out) according to the 1-hour algorithm
Time frame: 7-10 hours
The troponin tests will be sent to the laboratory for analysis every 4th hour. The tests are analyzed in 1-2 hours.
4 secondary outcomes
Number of patients with significant change in the 3rd troponin (drawn after 4-6 hours) who were not identified by the 1-hour algorithm
Time frame: 10 hours
Significant changes between the first and second ECG?
Time frame: 6 hours
Number of patients with NSTEMI admitted to the hospital from the Observation Unit at the OAEOC
Time frame: 1 week
90 days follow-up of all recruited patients
Time frame: 90 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 14 Mar 2019.
- Derived from this study: PubMed 40716792Johannessen TR, Melessen IMB, Vallersnes OM, Manten A, Halvorsen S, Atar D, Harskamp RE. Adequately identifying low-risk chest pain in emergency primary care: evaluating the performance of preHEAR(T) based on two European cohorts. Open Heart. 2025 Jul 27;12(2):e003362. doi: 10.1136/openhrt-2025-003362.
- Derived from this study: PubMed 35352564Johannessen TR, Halvorsen S, Atar D, Vallersnes OM. Performance of the Novel Observation Group Criteria of the European Society of Cardiology (ESC) 0/1-Hour Algorithm in a Low-Risk Population. J Am Heart Assoc. 2022 Apr 5;11(7):e024927. doi: 10.1161/JAHA.121.024927. Epub 2022 Mar 30. No abstract available.
- Derived from this study: PubMed 33627355Johannessen TR, Atar D, Vallersnes OM, Larstorp ACK, Mdala I, Halvorsen S. Comparison of a single high-sensitivity cardiac troponin T measurement with the HEART score for rapid rule-out of acute myocardial infarction in a primary care emergency setting: a cohort study. BMJ Open. 2021 Feb 24;11(2):e046024. doi: 10.1136/bmjopen-2020-046024.
- Derived from this study: PubMed 32719074Johannessen TR, Vallersnes OM, Halvorsen S, Larstorp ACK, Mdala I, Atar D. Pre-hospital One-Hour Troponin in a Low-Prevalence Population of Acute Coronary Syndrome: OUT-ACS study. Open Heart. 2020 Jul;7(2):e001296. doi: 10.1136/openhrt-2020-001296.
- Individual participant dataSharing planned: No
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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.
Dan Atar, MD, PhD study director
Oslo University Hospital and University of Oslo, Norway
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 Non-ST Elevation Myocardial Infarction and Acute Coronary Syndrome, run by Oslo University Hospital at 1 site in Norway.
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 4 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 14 Mar 2019. 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 Norway. 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?
Number of patients transferred to the hospital (rule-in) according to the 1-hour algorithm (time frame: 7-10 hours). The study lists 2 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 NCT02983123, which also lists 4 linked publications.
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 14 Mar 2019.