Troponin POCT in the Diagnosis of an Acute Myocardial Infarction

NCT03400553 | Completed

• 1 other identifier: Troponin-T POCT
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

Thoracic pain can be caused by a life threatening disease as for instance a heart attack. Fast diagnosis and treatment is necessary for an advantageous clinical outcome. When a patient enters the emergency unit, an electrocardiogram (ECG) can diagnose a heart attack by recording the electrical activity of the patients' heart. However, an increasing number of patients with an acute myocardial infarction (AMI) are presenting without significant abnormalities on ECG In the latter group, diagnosis is dependent of elevated biochemical markers of myocardiocyte necrosis in the blood such as troponin. Generally, troponins are determined in blood and are analyzed by radiometry or at the hospital's laboratory. Time loss in the acquisition of troponin levels can occur during the workflow due to blood sampling difficulties, transport of the blood samples, processing in the laboratory, and processes inherent to the measuring assays. Roche developed a portable point-of-care (POC) device that determines troponin-T in a few minutes by using small volumes of the patient's blood with the added value that this device can be used in a pre-hospital setting which might save a significant amount of time in determining troponin levels.In this way, a faster diagnosis of AMI can be made improving patients' outcome.

Conditions

Acute Myocardial Infarction; Troponin

Outcome Measures

Primary Outcomes (1)

• The time to diagnosis of acute myocardial infarction (AMI)

  The time between blood sample and the result of each device will be compared against the other devices. According to the troponin level, the diagnosis will be made. Troponin T\< 5 ng/L: negative for AMI; Troponin-T\>50 ng/L: positive for AMI; Troponin-T: 5-50 ng/L: observation and a second blood sample has to be taken for re-evaluation of troponin-T.

  one hour

Secondary Outcomes (1)

• Time since onset of chest pain to first blood sample

  one hour

Study Arms (1)

non-traumatic thoracic pain

EXPERIMENTAL

Patients with out-of-hospital non-traumatic thoracic pain admitted to the emergency unit via ambulance or MUG will be screened for enrolment. Blood analysis for troponin-T will be performed by 3 different devices as explained earlier.

Diagnostic Test: Blood analysis

Interventions

Blood analysis DIAGNOSTIC_TEST

The blood of the patients will be analyzed for troponin T measured with 3 different devices: 1) a point-of-care (POC) test performed in the ambulance or MUG, a handheld cobas h232 POC system® (Roche Diagnostics, Switzerland), 2) a POC test at the emergency room, a table top AQT90 FLEX® (Radiometer, The Netherlands) and 3) a central laboratory test performed on cobas® 8000 (Roche Diagnostics, Switzerland).

non-traumatic thoracic pain

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-traumatic thoracic pain
• Transportation via ambulance or MUG
• Written informed consent form (ICF) has to be obtained from the patient

You may not qualify if:

• Age \<18 years

Sponsors & Collaborators

• Ziekenhuis Oost-Limburg: lead

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Pascal Vanelderen, MD PhD

  Ziekenhuis Oost-Limburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 17, 2018
• Study Start: January 1, 2018
• Primary Completion: December 13, 2019
• Study Completion: January 15, 2020
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

BE (1)