Troponin POCT in the Diagnosis of an Acute Myocardial Infarction
Condition: Acute Myocardial Infarction; Troponin
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      Thoracic pain can be caused by a life threatening disease as for instance a heart attack.
      Fast diagnosis and treatment is necessary for an advantageous clinical outcome. When a
      patient enters the emergency unit, an electrocardiogram (ECG) can diagnose a heart attack by
      recording the electrical activity of the patients' heart. However, an increasing number of
      patients with an acute myocardial infarction (AMI) are presenting without significant
      abnormalities on ECG In the latter group, diagnosis is dependent of elevated biochemical
      markers of myocardiocyte necrosis in the blood such as troponin. Generally, troponins are
      determined in blood and are analyzed by radiometry or at the hospital's laboratory. Time loss
      in the acquisition of troponin levels can occur during the workflow due to blood sampling
      difficulties, transport of the blood samples, processing in the laboratory, and processes
      inherent to the measuring assays. Roche developed a portable point-of-care (POC) device that
      determines troponin-T in a few minutes by using small volumes of the patient's blood with the
      added value that this device can be used in a pre-hospital setting which might save a
      significant amount of time in determining troponin levels.In this way, a faster diagnosis of
      AMI can be made improving patients' outcome.
    

Detailed description: 
      In this prospective pilot study, 70 patients will be recruited over a time period of one
      year, with non-traumatic thoracic pain in a pre-hospital setting. While the ambulance or MUG
      is transporting such a patient, he/she is asked (informed consent) if an extra blood sample
      can be taken for measuring troponin levels by the portable device of Roche (cobas h232®).
      This can be done during the same venipuncture needed for standard-of-care analysis of the two
      other blood samples used for troponin-T by the radiometer and the laboratory. An ECG is
      performed in the ambulance and when it is positive, a patient is diagnosed immediately with
      acute myocardial infarction (AMI) and will be to transported as fast as possible to the
      coronary care unit. The blood samples retrieved in the ambulance are transported to the lab
      and to the table top radiometer in the emergency unit. As stated before, an increasing number
      of patients with AMI are presenting without significant abnormalities on ECG. Therefore, the
      troponin-T levels in the blood sample will provide extra information to make an appropriate
      diagnosis. It is our hypothesis, that the Cobas h232 device will provide faster results and
      thus a faster diagnosis of AMI which benefit patients' outcome.
    

Intervention name(s): Blood analysis
Intervention type(s): Diagnostic Test
Intervention description(s): The blood of the patients will be analyzed for troponin T measured with 3 different devices: 1) a point-of-care (POC) test performed in the ambulance or MUG, a handheld cobas h232 POC system® (Roche Diagnostics, Switzerland), 2) a POC test at the emergency room, a table top AQT90 FLEX® (Radiometer, The Netherlands) and 3) a central laboratory test performed on cobas® 8000 (Roche Diagnostics, Switzerland).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic