High-Sensitivity Troponin I in Addition to Guideline-Based Care in EMS

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska Institutet

About this trial

The TIGER study is a study investigating the utlility of a point-of-care blood analyse of Troponin I to help identify patients with heart attacks in the prehospital emergency care. The study is conducted within the ambulance services of Region Stockholm and compares standard medical care with and without the addition of this quick test.

Chest pain is one of the most common reasons for ambulance dispatch, but currently only about one-third of heart attacks are detected before arriving at the hospital-mainly through ECG. The remaining two-thirds are not identified until after further testing at the emergency department. The TIGER study aims to improve early diagnosis by using a high-sensitivity, point-of-care Troponin I test already in the prehospital phase.

The study is a randomized controlled trial, where participants are randomly assigned to one of two groups. One group receives standard emergency care along with the rapid Troponin I test in the ambulance. The other group receives standard care without the test. The goal is to evaluate whether the use of Troponin I testing leads to faster and more accurate identification of heart attacks, ultimately improving patient outcomes.

In total, about 1,419 adult patients with chest pain or suspected heart attack will participate. The primary outcome being measured is the time from first medical contact to PCI (balloon angioplasty). Secondary outcomes include time spent in different parts of care, hospital length of stay, the occurrence of serious events (such as heart attack, stroke, or death), and the diagnostic accuracy of the test.

The study has been approved by the Swedish Ethical Review Authority and includes safety monitoring through an interim analysis after the first 150 patients. Test results from the Troponin I analysis are clearly marked as part of the research study and should be interpreted by the responsible physician alongside other clinical findings.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Chestpain / discomfort and/or

Clinical suspicion of myocardial infarction by the prehospital personeel

Disqualifiers

Patients suffering from a trauma and conveyed to the trauma level 1 hospital.

Missing valid social security number

Not beeing able to give informed consent

Not a primary assignment

Trial design

Design model

Parallel

Treatments tested in this trial

  • high sensitivity Troponin I

    Diagnostic test

    Study participants in the intervention group will have the high-sensitivity Troponin I blood test analyzed during emergency medical service (EMS) care using the point-of-care Siemens Atellica® VTLi system. The test result will be documented in the EMS electronic medical record (FRAPP), transmitted along with the ECG, and communicated verbally to the receiving hospital during handover.

Treatment groups

1,419 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Time from First Medical Contact to Vascular Access (FMC-to-Access Time)

Time in minutes from the initial contact with emergency medical services (EMS) to vascular access (arterial puncture) for percutaneous coronary intervention (PCI), representing the time to initiation of the invasive procedure.

Time frame
From time of first medical contact by EMS to time of vascular access during index PCI procedure, assessed during index hospitalization (typically within 72 hours)

Secondary outcomes

1

Time from First Medical Contact to Initial ECG (FMC-to-ECG Time)

Time in minutes from the first contact with emergency medical services (EMS) personnel-defined as the moment EMS arrives at the patient-to completion of the first 12-lead ECG.

Time frame
From time of initial patient contact by EMS personnel to time of first ECG, assessed during prehospital phase (typically within 1 hour)
2

Time from First Medical Contact to Emergency Department Admission (FMC-to-ED Admission Time)

Time in minutes from first EMS contact to arrival and registration at the emergency department.

Time frame
From time of first medical contact to ED admission, assessed on the day of presentation (typically within 4 hours)
3

Emergency Department Length of Stay

Duration in minutes from emergency department registration to transfer or discharge from the ED.

Time frame
From time of ED admission to ED discharge, assessed during index visit (typically within 24 hours)
4

Total Hospital Length of Stay

Duration in minutes from emergency department admission to hospital discharge (from acute care facility).

Time frame
From ED admission to hospital discharge, assessed during index hospitalization (up to 14 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska Institutet

Lead sponsor

Region Stockholm

Collaborator