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

NCT07008391 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1419

Last updated 2025-07-02

No results posted yet for this study

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.

Conditions

  • Emergency Medical Services
  • Nursing Care
  • Cardiology
  • Myocardial Infarction
  • Myocardial Infarction or Chest Pain
  • Myocardial Infarction, Acute
  • Emergencies
  • Ambulance

Interventions

DIAGNOSTIC_TEST

high sensitivity Troponin I

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.

Sponsors & Collaborators

  • Ambulance care in Greater Stockholm Ltd (AISAB), Region Stockholm

    collaborator UNKNOWN
  • Karolinska Institutet

    lead OTHER

Principal Investigators

  • Jakob Lederman, PhD · Karolinska Institute, Department of Clinical Science and Education

  • Veronica Vicente, Docent · Karolinska Institute, Department of Clinical Science and Education

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-25
Primary Completion
2026-06-30
Completion
2026-12-30

Countries

  • Sweden

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07008391 on ClinicalTrials.gov