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Completed

NCT Number: NCT02983123

One-hour Troponin in a Low-prevalence Population of Acute Coronary Syndrome

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.

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Key information

Conditions

Non-ST Elevation Myocardial Infarction Acute Coronary Syndrome Angina Pectoris Angina, Unstable Cardiovascular Diseases Chest Pain Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia NSTEMI - Non-ST Segment Elevation MI Necrosis Neurologic Manifestations Non-ST Elevated Myocardial Infarction Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo Accident and Emergency Outpatient Clinic

Oslo, 0182, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1-hour hs-cTnT

Procedure

Primary outcomes

  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 outcomes

  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?

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • University of Oslo

Registry information

Official study 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

Acronym: OUT-ACS

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 6, 2016
Registry last updated
Mar 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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