Troponin POCT in the Diagnosis of an Acute Myocardial Infarction
Primary Purpose
Acute Myocardial Infarction, Troponin
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Blood analysis
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Myocardial Infarction
Eligibility Criteria
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
Sites / Locations
- Ziekenhuis Oost-Limburg
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
non-traumatic thoracic pain
Arm Description
Patients with out-of-hospital non-traumatic thoracic pain admitted to the emergency unit via ambulance or MUG will be screened for enrolment. Blood analysis for troponin-T will be performed by 3 different devices as explained earlier.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03400553
First Posted
January 9, 2018
Last Updated
April 12, 2023
Sponsor
Ziekenhuis Oost-Limburg
1. Study Identification
Unique Protocol Identification Number
NCT03400553
Brief Title
Troponin POCT in the Diagnosis of an Acute Myocardial Infarction
Official Title
Time Gain of Pre-hospital Troponin Point of Care Testing in the Diagnosis of an Acute Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 13, 2019 (Actual)
Study Completion Date
January 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ziekenhuis Oost-Limburg
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction, Troponin
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
non-traumatic thoracic pain
Arm Type
Experimental
Arm Description
Patients with out-of-hospital non-traumatic thoracic pain admitted to the emergency unit via ambulance or MUG will be screened for enrolment. Blood analysis for troponin-T will be performed by 3 different devices as explained earlier.
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood analysis
Intervention Description
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).
Primary Outcome Measure Information:
Title
The time to diagnosis of acute myocardial infarction (AMI)
Description
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.
Time Frame
one hour
Secondary Outcome Measure Information:
Title
Time since onset of chest pain to first blood sample
Description
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.
Time Frame
one hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal Vanelderen, MD PhD
Organizational Affiliation
Ziekenhuis Oost-Limburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
ZIP/Postal Code
3600
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Troponin POCT in the Diagnosis of an Acute Myocardial Infarction
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