NCT02972814

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 23, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

April 21, 2021

Status Verified

April 1, 2021

Enrollment Period

3.4 years

First QC Date

November 11, 2016

Last Update Submit

April 20, 2021

Conditions

Non STEMIAngina PectorisAngina, StableAngina, UnstableAngina, Prinzmetal's

Keywords

TroponinPoint of care testmyocardial infarction

Outcome Measures

Primary Outcomes (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

Study Arms (1)

Thoracic pain

Patients presenting to the emergency room with thoracic pain probably due to a non-STEMI

Device: Laboratory based troponin testDevice: Point of care based troponin test 1Device: Point of care based troponin test 2

Interventions

Laboratory based troponin testDEVICE

acquisition of blood troponin level by Roche Cobas E 603

Thoracic pain
Point of care based troponin test 1DEVICE

acquisition of blood troponin level by Radiometer EQT 90 Flex

Thoracic pain
Point of care based troponin test 2DEVICE

acquisition of blood troponin level by Philips Minicare I-20

Thoracic pain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients presenting to the emergency room with thoracic pain due to a non-STEMI

You may qualify if:

  • Thoracic pain

You may not qualify if:

  • Unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Location

MeSH Terms

Conditions

Non-ST Elevated Myocardial InfarctionAngina PectorisAngina, StableAngina, UnstableAngina Pectoris, VariantMyocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisChest PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Pascal Vanelderen, MD, PhDD

    Member of Staff

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr.

Study Record Dates

First Submitted

November 11, 2016

First Posted

November 23, 2016

Study Start

February 1, 2017

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

April 21, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)