Clinical trial NCT07008391: High-Sensitivity Troponin I in Addition to Guideline-Based Care in EMS
Official title: High-Sensitivity Troponin I in Addition to Guideline-Based Care in Emergency Medical Service - an Open Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Emergency Medical Services
Nursing Care
Cardiology
Myocardial Infarction
Myocardial Infarction or Chest Pain
Myocardial Infarction, Acute
Emergencies
Ambulance
Keywords: Ambulance
Prehospital emergency nurse
Sweden
Point-of-care
troponin
high sensitive troponin
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Ambulance care in Greater Stockholm Ltd (AISAB), Region Stockholm
First posted: 2025-06-06
Enrollment: 1419
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2:1 Randomization
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: The TIGER study is a prospective, open-label, randomized controlled trial designed to evaluate the clinical utility of prehospital high-sensitivity Troponin I testing in patients presenting with chest pain or suspected myocardial infarction (MI). The study is conducted within the emergency medical services (EMS) in Stockholm, Sweden.

Participants are randomized in a 2:1 ratio to receive either standard guideline-based care alone or standard care plus point-of-care Troponin I testing using the Siemens Atellica® VTLi system. The Troponin result is available to EMS providers in real-time and is communicated to the receiving hospital as part of the routine prehospital handover.

The study aims to assess whether the addition of early biomarker data can improve triage, reduce time to treatment (FMC-to-balloon time), and optimize the use of healthcare resources. An interim analysis will be conducted after 150 patients have been enrolled. The study has been approved by the Swedish Ethical Review Authority.

Eligibility criteria: Inclusion Criteria:

* Chestpain / discomfort and/or
* Clinical suspicion of myocardial infarction by the prehospital personeel

Exclusion Criteria:

* 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

Primary outcomes:
measure: Time from First Medical Contact to Vascular Access (FMC-to-Access Time)
timeFrame: 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:
measure: Time from First Medical Contact to Initial ECG (FMC-to-ECG Time)
timeFrame: From time of initial patient contact by EMS personnel to time of first ECG, assessed during prehospital phase (typically within 1 hour)
measure: Time from First Medical Contact to Emergency Department Admission (FMC-to-ED Admission Time)
timeFrame: From time of first medical contact to ED admission, assessed on the day of presentation (typically within 4 hours)
measure: Emergency Department Length of Stay
timeFrame: From time of ED admission to ED discharge, assessed during index visit (typically within 24 hours)
measure: Total Hospital Length of Stay
timeFrame: From ED admission to hospital discharge, assessed during index hospitalization (up to 14 days)
measure: Major Adverse Cardiovascular Events (MACE)
timeFrame: Assessed at 72 hours and at 30 days from the time of first medical contact, defined as the arrival of emergency medical services (EMS)
measure: Number of Interventions Performed During Acute Care Episode
timeFrame: From the time of first medical contact-defined as the arrival of EMS personnel at the patient's side-through hospital discharge, assessed during the full acute care episode (up to 14 days)
measure: Proportion of participants assigned to in-hospital care
timeFrame: From admission to discharge, during index hospitalization (up to 14 days)
measure: Clinical Utility: Sensitivity, Specificity, Negative Predictive Value (NPV), and Positive Predictive Value (PPV).
timeFrame: From the time of EMS assessment (first medical contact) to confirmation of final diagnosis at hospital discharge (typically within 7-14 days)
measure: Incidence of Other Time-Critical Medical Conditions
timeFrame: Assessed up to 30 days from the time of first medical contact by emergency medical services (EMS)
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Ambulance care in greater Stockholm Ltd. (AISAB)
state: Årsta
Study officials:
affiliation: Karolinska Institute, Department of Clinical Science and Education
name: Jakob Lederman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institute, Department of Clinical Science and Education
name: Veronica Vicente, Docent
role: STUDY_CHAIR
References: