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

Overview

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.

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.

Primary outcome measures

• Time from First Medical Contact to Vascular Access (FMC-to-Access Time) [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 outcome measures (9)

• Time from First Medical Contact to Initial ECG (FMC-to-ECG Time) [Time frame: 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) [Time frame: From time of first medical contact to ED admission, assessed on the day of presentation (typically within 4 hours)]
• Emergency Department Length of Stay [Time frame: From time of ED admission to ED discharge, assessed during index visit (typically within 24 hours)]
• Total Hospital Length of Stay [Time frame: From ED admission to hospital discharge, assessed during index hospitalization (up to 14 days)]
• Major Adverse Cardiovascular Events (MACE) [Time frame: Assessed at 72 hours and at 30 days from the time of first medical contact, defined as the arrival of emergency medical services (EMS)]
• Number of Interventions Performed During Acute Care Episode [Time frame: 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)]
• Proportion of participants assigned to in-hospital care [Time frame: From admission to discharge, during index hospitalization (up to 14 days)]
• Clinical Utility: Sensitivity, Specificity, Negative Predictive Value (NPV), and Positive Predictive Value (PPV). [Time frame: From the time of EMS assessment (first medical contact) to confirmation of final diagnosis at hospital discharge (typically within 7-14 days)]
• Incidence of Other Time-Critical Medical Conditions [Time frame: Assessed up to 30 days from the time of first medical contact by emergency medical services (EMS)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

Sweden · 1 center

• Ambulance care in greater Stockholm Ltd. (AISAB) — Stockholm

Identifiers

NCT: NCT07008391 · 2023-07919-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗