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| ID | Type | Description | Link |
|---|---|---|---|
| 2016/13308 | Other Identifier | PVO OUS |
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| Name | Class |
|---|---|
| University of Oslo | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1-hour hs-cTnT | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 7-10 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with significant change in the 3rd troponin (drawn after 4-6 hours) who were not identified by the 1-hour algorithm | 10 hours | |
| Significant changes between the first and second ECG? | 6 hours |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Dan Atar, MD, PhD | Oslo University Hospital and University of Oslo, Norway | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo Accident and Emergency Outpatient Clinic | Oslo | 0182 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40716792 | Derived | 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. | |
| 35352564 | Derived |
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| ID | Term |
|---|---|
| D000072658 | Non-ST Elevated Myocardial Infarction |
| D054058 | Acute Coronary Syndrome |
| D000789 | Angina, Unstable |
| D002637 | Chest Pain |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 | 1 week |
| 90 days follow-up of all recruited patients | How many will have an acute MI the next 3 months? | 90 days |
| Johannessen 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. |
| 33627355 | Derived | Johannessen 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. |
| 32719074 | Derived | Johannessen 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. |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D000787 | Angina Pectoris |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |