Acute Myocardial Infarction Clinical Trial
Official title:
Time Gain of Pre-hospital Troponin Point of Care Testing in the Diagnosis of an Acute Myocardial Infarction
Verified date | April 2023 |
Source | Ziekenhuis Oost-Limburg |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 71 |
Est. completion date | January 15, 2020 |
Est. primary completion date | December 13, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - Non-traumatic thoracic pain - Transportation via ambulance or MUG - Written informed consent form (ICF) has to be obtained from the patient Exclusion Criteria: - Age <18 years |
Country | Name | City | State |
---|---|---|---|
Belgium | Ziekenhuis Oost-Limburg | Genk |
Lead Sponsor | Collaborator |
---|---|
Ziekenhuis Oost-Limburg |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The time to diagnosis of acute myocardial infarction (AMI) | The time between blood sample and the result of each device will be compared against the other devices. According to the troponin level, the diagnosis will be made. Troponin T< 5 ng/L: negative for AMI; Troponin-T>50 ng/L: positive for AMI; Troponin-T: 5-50 ng/L: observation and a second blood sample has to be taken for re-evaluation of troponin-T. | one hour | |
Secondary | Time since onset of chest pain to first blood sample | The time since onset of chest pain will be asked to the patient. The faster a patient will call to the emergency unit, the better the outcome. | one hour |
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