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

NCT07008391 | Recruiting

• 1 other identifier: 2023-07919-01
• Study Type: interventional
• Target: 1,419
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

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.

  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 (9)

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

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

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

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

• Emergency Department Length of Stay

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

• Total Hospital Length of Stay

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

• Major Adverse Cardiovascular Events (MACE)

  Assessed at 72 hours and at 30 days from the time of first medical contact, defined as the arrival of emergency medical services (EMS)

Study Arms (2)

Intervention

EXPERIMENTAL

Getting a point-of-care Troponin I analysed, in addition to care according to medical guidelines in EMS

Diagnostic Test: high sensitivity Troponin I

Control

NO INTERVENTION

Getting care according to medical guidelines in EMS

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Ambulance care in Greater Stockholm Ltd (AISAB), Region Stockholm: collaborator

Study Sites (1)

Ambulance care in greater Stockholm Ltd. (AISAB)

Stockholm, Årsta, 12040, Sweden

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction; Chest Pain; Emergencies

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Pain; Neurologic Manifestations; Signs and Symptoms; Disease Attributes

Study Officials

• Jakob Lederman, PhD

  Karolinska Institute, Department of Clinical Science and Education

  PRINCIPAL INVESTIGATOR

• Veronica Vicente, Docent

  Karolinska Institute, Department of Clinical Science and Education

  STUDY CHAIR

Central Study Contacts

Jakob Lederman, PhD

CONTACT

0812313189; jakob.lederman@ki.se

Sebastian Bjöhle, Doctoral student

CONTACT

0812312078; sebastian.bjohle@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 2:1 Randomization

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: June 6, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)