Emergency Medical ServicesTIGERNCT07008391
High-Sensitivity Troponin I in Addition to Guideline-Based Care in EMS
A study testing high sensitivity Troponin I in people with Emergency Medical Services and Nursing Care, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emergency Medical Services, Nursing Care, Cardiology
- What is being tested?
- high sensitivity Troponin I
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,419 participants
- Where
- 1 siteSweden
- Study dates
- 25 Jun 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chestpain / discomfort and/or
- Clinical suspicion of myocardial infarction by the prehospital personeel
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Ambulance care in greater Stockholm Ltd. (AISAB)
Stockholm, Årsta, 12040
Veronica Vicente, Head of research and inovation, Ass. Professor, +46 8 123 120 00, veronica.vicente@regionstockholm.se
Jakob Lederman, Phd
About this study
Official title: High-Sensitivity Troponin I in Addition to Guideline-Based Care in Emergency Medical Service - an Open Randomized Controlled Trial
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.
Read more
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.
Read the 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.
- Conditions
- Emergency Medical Services, Nursing Care, Cardiology, Myocardial Infarction, Myocardial Infarction or Chest Pain, Myocardial Infarction, Acute
- Being tested
- high sensitivity Troponin I
- Keywords
- Ambulance, Prehospital emergency nurse, Sweden, Point-of-care, troponin, high sensitive troponin
- Medical subject headings
- Myocardial Infarction, Chest Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high sensitivity Troponin IDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Getting a point-of-care Troponin I analysed, in addition to care according to medical guidelines in EMS Receives: Diagnostic Test: high sensitivity Troponin I |
| Control | No intervention | Getting care according to medical guidelines in EMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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 in minutes from first EMS contact to arrival and registration at the emergency department.
Measured: From time of first medical contact to ED admission, assessed on the day of presentation (typically within 4 hours)
Emergency Department Length of Stay
Duration in minutes from emergency department registration to transfer or discharge from the ED.
Measured: From time of ED admission to ED discharge, assessed during index visit (typically within 24 hours)
Total Hospital Length of Stay
Duration in minutes from emergency department admission to hospital discharge (from acute care facility).
Measured: From ED admission to hospital discharge, assessed during index hospitalization (up to 14 days)
Major Adverse Cardiovascular Events (MACE)
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).
Measured: 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
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.
Measured: 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
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:
- Emergency Department (ED) only
- Direct to Percutaneous Coronary Intervention (PCI)
- Cardiac Intensive Care Unit (CICU)
- Intermediate Care Unit
- Other Cardiac Unit
- General Care Unit
- External Care Institution (e.g., step-down or rehabilitation facility)
Unit of Measure: Percentage of participants (%)
Measured: From admission to discharge, during index hospitalization (up to 14 days)
Clinical Utility: Sensitivity, Specificity, Negative Predictive Value (NPV), and Positive Predictive Value (PPV).
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.
Measured: 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
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.
Measured: Assessed up to 30 days from the time of first medical contact by emergency medical services (EMS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start25 Jun 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency Medical ServicesStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2:1 Randomization
- Masking
- None (open label)
- Enrolment
- 1,419 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Jakob Lederman, Karolinska Institutet
- Investigators
- Jakob Lederman, PhD, Principal investigator, Karolinska Institute, Department of Clinical Science and EducationVeronica Vicente, Docent, Study chair, Karolinska Institute, Department of Clinical Science and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008391
- Sponsor's protocol ID
- 2023-07919-01
- Other IDs
- 2023
- Acronym
- TIGER
- Status last verified
- Jun 2025
- First submitted
- 16 May 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared because consent for data sharing was not obtained from participants and data sharing is not feasible due to ethical restrictions
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Sensitivity Troponin I in Addition to Guideline-Based Care in Emergency Medical Service - an Open Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07008391
- Acronym / sponsor ID
- TIGER / 2023-07919-01
- Conditions
- Emergency Medical Services, Nursing Care, Cardiology, Myocardial Infarction, Myocardial Infarction or Chest Pain, Myocardial Infarction, Acute
- Keywords
- Ambulance, Prehospital emergency nurse, Sweden, Point-of-care, troponin, high sensitive troponin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,419 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2:1 Randomization
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Diagnostic Test: high sensitivity Troponin IGetting a point-of-care Troponin I analysed, in addition to care according to medical guidelines in EMS |
| Control | No intervention | –Getting care according to medical guidelines in EMS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chestpain / discomfort and/or
- Clinical suspicion of myocardial infarction by the prehospital personeel
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high sensitivity Troponin IStudy 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. | Diagnostic test | Intervention |
Primary outcome
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)
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.
9 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: No. IPD will not be shared because consent for data sharing was not obtained from participants and data sharing is not feasible due to ethical restrictions
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jakob Lederman, PhD principal investigator
Karolinska Institute, Department of Clinical Science and Education
Veronica Vicente, Docent study chair
Karolinska Institute, Department of Clinical Science and Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high sensitivity Troponin I in people with Emergency Medical Services and Nursing Care, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jakob Lederman, PhD (0812313189 ext. +46, jakob.lederman@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.