High-Sensitivity Troponin I in Addition to Guideline-Based Care in Emergency Medical Service - an Open Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,419
- 试验地点
- 2
- 主要终点
- Time from First Medical Contact to Vascular Access (FMC-to-Access Time)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chestpain / discomfort and/or
- •Clinical suspicion of myocardial infarction by the prehospital personeel
排除标准
- •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
结局指标
主要结局
Time from First Medical Contact to Vascular Access (FMC-to-Access Time)
时间窗: 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.
次要结局
- 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))
- Number of Interventions Performed During Acute Care Episode(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(From admission to discharge, during index hospitalization (up to 14 days))
- Clinical Utility: Sensitivity, Specificity, Negative Predictive Value (NPV), and Positive Predictive Value (PPV).(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(Assessed up to 30 days from the time of first medical contact by emergency medical services (EMS))
研究者
Jakob Lederman
PhD
Karolinska Institutet