T-POCT: Time Gain in the Diagnosis Myocardial Infarction by Troponin Point of Care Testing in the Emergency Room

• Sponsor: Ziekenhuis Oost-Limburg (Other)
• Overall Status: Completed
• CT.gov ID: NCT02972814
• Collaborator: (none)
• Enrollment: 66
• Location: 1
• Actual Duration (Months): 40.9
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non STEMI; Angina Pectoris; Angina, Stable; Angina, Unstable; Angina, Prinzmetal's	Device: Laboratory based troponin test; Device: Point of care based troponin test 1; Device: Point of care based troponin test 2

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 Design

• Study Type: Observational
• Actual Enrollment: 66 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Time Gain in the Diagnosis of Non-ST Elevation Myocardial Infarction by Troponin Point of Care Testing in the Emergency Room
• Actual Study Start Date: Feb 1, 2017
• Actual Primary Completion Date: Jun 30, 2020
• Actual Study Completion Date: Jun 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Thoracic pain Patients presenting to the emergency room with thoracic pain probably due to a non-STEMI	Device: Laboratory based troponin test; acquisition of blood troponin level by Roche Cobas E 603; Device: Point of care based troponin test 1; acquisition of blood troponin level by Radiometer EQT 90 Flex; Device: Point of care based troponin test 2; acquisition of blood troponin level by Philips Minicare I-20

Outcome Measures

Primary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Thoracic pain

Exclusion Criteria:

• Unable to give informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ziekenhuis Oost-Limburg	Genk	Limburg	Belgium	3600

Sponsors and Collaborators

• Ziekenhuis Oost-Limburg

Investigators

• Principal Investigator: Pascal Vanelderen, MD, PhDD, Member of Staff

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pascal Vanelderen, Prof. dr., Ziekenhuis Oost-Limburg
• ClinicalTrials.gov Identifier: NCT02972814
• Other Study ID Numbers: 16/093U
• First Posted: Nov 23, 2016
• Last Update Posted: Apr 21, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Pascal Vanelderen, Prof. dr., Ziekenhuis Oost-Limburg: Troponin; Point of care test; myocardial infarction
• Additional relevant MeSH terms: Myocardial Infarction; Angina Pectoris; Angina, Unstable; Angina, Stable; Angina Pectoris, Variant; Infarction; Emergencies

Study Results

No Results Posted as of Apr 21, 2021