Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT07008391

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

Led by Karolinska Institutet · Updated on 2025-07-02

1419

Participants Needed

1

Research Sites

79 weeks

Total Duration

On this page

Sponsors

K

Karolinska Institutet

Lead Sponsor

R

Region Stockholm

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults with chest pain or discomfort
  • Adults with clinical suspicion of myocardial infarction by prehospital personnel
Not Eligible

You will not qualify if you...

  • Patients with trauma being taken to a trauma level 1 hospital
  • Missing a valid social security number
  • Unable to give informed consent
  • Not a primary assignment for EMS

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Trial Site Locations

Total: 1 location

1

Ambulance care in greater Stockholm Ltd. (AISAB)

Stockholm, Årsta, Sweden, 12040

Actively Recruiting

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Research Team

J

Jakob Lederman, PhD

CONTACT

S

Sebastian Bjöhle, Doctoral student

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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