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

Completed

• Conditions: Angina, Unstable; Angina Pectoris; Non STEMI; Angina, Stable; Angina, Prinzmetal's
• Interventions: Device: Laboratory based troponin test; Device: Point of care based troponin test 1; Device: Point of care based troponin test 2

• Registration Number: NCT02972814
• Lead Sponsor: Ziekenhuis Oost-Limburg

Brief 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.

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:

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.

Study Timeline

• Study First Submitted: 2016-11-11
• Study First Submitted QC: 2016-11-21
• Study First Posted: 2016-11-23
• Study Start: 2017-02-01
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-20
• Last Update Posted: 2021-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Thoracic pain

Exclusion Criteria

• Unable to give informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Thoracic pain	Point of care based troponin test 2	Patients presenting to the emergency room with thoracic pain probably due to a non-STEMI
Thoracic pain	Laboratory based troponin test	Patients presenting to the emergency room with thoracic pain probably due to a non-STEMI
Thoracic pain	Point of care based troponin test 1	Patients presenting to the emergency room with thoracic pain probably due to a non-STEMI

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Limburg, Belgium