Time Gain in the Diagnosis Myocardial Infarction by Troponin Point of Care Testing in the Emergency Room

Angina Pectoris Clinical Trial

— T-POCT  

Official title:

Time Gain in the Diagnosis of Non-ST Elevation Myocardial Infarction by Troponin Point of Care Testing in the Emergency Room

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02972814
• Other study ID #: 16/093U
• Status: Completed
• Start date: February 1, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: April 2021
• Source: Ziekenhuis Oost-Limburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

The tests are one laboratory based test and two point of care tests.

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:

1. A laboratory based test: Roche Cobas E 602

2. A point of care test: Radiometer AQT 90 Flex

3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Thoracic pain

Exclusion Criteria:

• Unable to give informed consent

Related Conditions & MeSH terms

• Angina Pectoris
• Angina Pectoris, Variant
• Angina, Prinzmetal's
• Angina, Stable
• Angina, Unstable
• Emergencies
• Infarction
• Myocardial Infarction
• Non STEMI

Intervention

Device:
• Laboratory based troponin test
acquisition of blood troponin level by Roche Cobas E 603
• Point of care based troponin test 1
acquisition of blood troponin level by Radiometer EQT 90 Flex
• Point of care based troponin test 2
acquisition of blood troponin level by Philips Minicare I-20

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time delay until troponin test results are known		From the time of venipuncture to the time the troponin test results are known: up to 6 hours