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One-hour Troponin in a Low-prevalence Population of Acute Coronary Syndrome (OUT-ACS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02983123
Recruitment Status : Completed
First Posted : December 6, 2016
Last Update Posted : March 14, 2019
Sponsor:
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Dan Atar, Oslo University Hospital

Brief 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). 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.

Condition or disease Intervention/treatment
Non-ST Elevation Myocardial Infarction Acute Coronary Syndrome Angina, Unstable NSTEMI - Non-ST Segment Elevation MI Procedure: 1-hour hs-cTnT

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.

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Study Type : Observational
Actual Enrollment : 1750 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : November 15, 2016
Actual Primary Completion Date : October 22, 2018
Actual Study Completion Date : October 22, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Procedure: 1-hour hs-cTnT



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. Significant changes between the first and second ECG? [ Time Frame: 6 hours ]
  3. Number of patients with NSTEMI admitted to the hospital from the Observation Unit at the OAEOC [ Time Frame: 1 week ]
    The final diagnosis will be collected from all patients who were admitted to the hospital from the Observation Unit during the study

  4. 90 days follow-up of all recruited patients [ Time Frame: 90 days ]
    How many will have an acute MI the next 3 months?



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02983123


Locations
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Norway
Oslo Accident and Emergency Outpatient Clinic
Oslo, Norway, 0182
Sponsors and Collaborators
Oslo University Hospital
University of Oslo
Investigators
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Study Director: Dan Atar, MD, PhD Oslo University Hospital and University of Oslo, Norway
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dan Atar, Professor of Cardiology and Head of Research, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02983123    
Other Study ID Numbers: 2016/1241/REK
2016/13308 ( Other Identifier: PVO OUS )
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dan Atar, Oslo University Hospital:
Acute MI
Acute myocardial infarction cardiac troponin
High-sensitivity cardiac troponin T
0/1-hour algorithm
Outpatient clinic
Cardiac troponin
Chest pain
Additional relevant MeSH terms:
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Myocardial Infarction
Acute Coronary Syndrome
Non-ST Elevated Myocardial Infarction
Angina, Unstable
Syndrome
Infarction
Disease
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations