Non STEMIT-POCTNCT02972814
Time Gain in the Diagnosis Myocardial Infarction by Troponin Point of Care Testing in the Emergency Room
An observational study of Non STEMI and Angina Pectoris, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial summary
The investigators prospectively want to compare 3 clinical tests for measuring blood troponin levels in patients presenting to the emergency room with thoracic pain probably related to a myocardial infarction with regard to the time necessary to obtain the test results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non STEMI, Angina Pectoris, Angina, Stable
- What is being tested?
- Laboratory based troponin test, Point of care based troponin test 1 and Point of care based troponin test 2
- Type of treatment
- Medical device
- How many people
- 66 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2017to 30 Jun 2020
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to the emergency room with thoracic pain due to a non-STEMI
Who may be able to join
- Thoracic pain
Who cannot join
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Time Gain in the Diagnosis of Non-ST Elevation Myocardial Infarction by Troponin Point of Care Testing in the Emergency Room
The investigators prospectively want to compare 3 clinical tests for measuring blood troponin levels in patients presenting to the emergency room with thoracic pain probably related to a myocardial infarction with regard to the time necessary to obtain the test results.
The tests are one laboratory based test and two point of care tests.
Read the detailed description
Thoracic pain can be caused by a myocardial infarction. The diagnosis of a myocardial infarction can be made by an ECG (ST-elevation myocardial infarction, STEMI). However, some myocardial infarctions can also occur without ST-elevations on the ECG (non-ST-elevation myocardial infarction, non-STEMI). In the latter case, a quick acquisition of blood troponin levels is necessary to coin the diagnosis and initiate treatment. Therefore, the investigators prospectively want to compare 3 clinical tests for measuring blood troponin levels in patients presenting to the emergency room with thoracic pain probably related to a non-STEMI with regard to the time necessary to obtain the test results.
The 3 tests are:
- A laboratory based test: Roche Cobas E 602
- A point of care test: Radiometer AQT 90 Flex
- A point of care test: Philips Minicare I-20
The measured timeframe is the time between venipuncture to the point the test results are known.
- Being tested
- Laboratory based troponin test, Point of care based troponin test 1, Point of care based troponin test 2
- Keywords
- Troponin, Point of care test, myocardial infarction
- Medical subject headings
- Non-ST Elevated Myocardial Infarction, Angina Pectoris, Angina, Stable, Angina, Unstable, Angina Pectoris, Variant, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory based troponin testDevice
acquisition of blood troponin level by Roche Cobas E 603
Point of care based troponin test 1Device
acquisition of blood troponin level by Radiometer EQT 90 Flex
Point of care based troponin test 2Device
acquisition of blood troponin level by Philips Minicare I-20
| Study group | Role | What they receive |
|---|---|---|
| Thoracic pain | Patients presenting to the emergency room with thoracic pain probably due to a non-STEMI Receives: Device: Laboratory based troponin test; Device: Point of care based troponin test 1; Device: Point of care based troponin test 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
time delay until troponin test results are known
Measured: From the time of venipuncture to the time the troponin test results are known: up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study start1 Feb 2017
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non STEMIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pascal Vanelderen, Ziekenhuis Oost-Limburg
- Investigators
- Pascal Vanelderen, MD, PhDD, Principal investigator, Member of Staff
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972814
- Sponsor's protocol ID
- 16/093U
- Acronym
- T-POCT
- Status last verified
- Apr 2021
- First submitted
- 11 Nov 2016
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No