NCT Number: NCT07008391
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Stockholm, Årsta, 12040, Sweden
Location status: Recruiting
Jakob Lederman, Phd
PRINCIPAL_INVESTIGATOR
Sebastian Bjöhle, Doctoral student
SUB_INVESTIGATOR
Veronica Vicente, Ass. professor
SUB_INVESTIGATOR
Veronica Vicente, Head of research and inovation, Ass. Professor
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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)
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.
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 in minutes from the first contact with emergency medical services (EMS) personnel-defined as the moment EMS arrives at the patient-to completion of the first 12-lead ECG.
Time frame: From time of first medical contact to ED admission, assessed on the day of presentation (typically within 4 hours)
Time in minutes from first EMS contact to arrival and registration at the emergency department.
Time frame: From time of ED admission to ED discharge, assessed during index visit (typically within 24 hours)
Duration in minutes from emergency department registration to transfer or discharge from the ED.
Time frame: From ED admission to hospital discharge, assessed during index hospitalization (up to 14 days)
Duration in minutes from emergency department admission to hospital discharge (from acute care facility).
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)
Composite outcome including the occurrence of any of the following within the specified time frames: myocardial infarction, angina pectoris, all-cause mortality, stroke, or heart failure with reduced ejection fraction (HFrEF).
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)
Total number of interventions performed per patient from first medical contact through hospital discharge. Interventions may include prehospital treatments (e.g., defibrillation, medication administration) and in-hospital procedures such as diagnostic angiography, percutaneous coronary intervention (PCI), temporary pacing, or surgery.
Time frame: From admission to discharge, during index hospitalization (up to 14 days)
Proportion of participants assigned to each predefined category of in-hospital care, based on the most resource-intensive setting they were treated in during the index hospitalization. The categories include:
Unit of Measure: Percentage of participants (%)
Time frame: From the time of EMS assessment (first medical contact) to confirmation of final diagnosis at hospital discharge (typically within 7-14 days)
Diagnostic performance of prehospital assessment for identifying patients with Myocardial infarction. Includes calculation of sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV), using confirmed diagnosis (ICD-code) at discharge as reference standard.
Time frame: Assessed up to 30 days from the time of first medical contact by emergency medical services (EMS)
Number of participants diagnosed with other time-critical medical conditions within 30 days of first medical contact. These may include but are not limited to: stroke, sepsis, aortic dissection, pulmonary embolism, or major trauma.
Contact information is provided by the study sponsor or research team.
Jakob Lederman, PhD
CONTACT
0812313189 ext. +46
Sebastian Bjöhle, Doctoral student
CONTACT
0812312078 ext. +46
Karolinska Institutet
Other
High-Sensitivity Troponin I in Addition to Guideline-Based Care in Emergency Medical Service - an Open Randomized Controlled Trial
Acronym: TIGER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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