Rapid high-sensitivity Troponin I testing in ambulance care
Official title: High-Sensitivity Troponin I in Addition to Guideline-Based Care in Emergency Medical Service - an Open Randomized Controlled Trial
Run by Karolinska Institutet · NCT07008391 · Data updated 2026-11-12
This tests whether a rapid high-sensitivity troponin I blood test used by ambulance crews helps identify heart attacks earlier in people with chest pain or suspected myocardial infarction.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1419 (estimated) |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Stockholm, Årsta) |
| Status | Recruiting |
| Started | June 25, 2025 |
| Main results expected | June 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | July 2, 2025 |
| Trial ID | NCT07008391 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults encountered by Stockholm ambulance crews who have chest pain, discomfort, or clinical suspicion of myocardial infarction are ideal candidates for the study.
✕Probably not a fit
Patients with traumatic injuries, those without a valid Swedish social security number, or those unable to give informed consent are excluded and unlikely to benefit from the intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
TIGER is a prospective, open-label randomized controlled trial in the Stockholm EMS that randomizes patients with chest pain or suspected MI in a 2:1 ratio to standard guideline-based prehospital care with or without point-of-care high-sensitivity Troponin I testing using the Siemens Atellica VTLi system. The troponin result is available in real time to ambulance personnel and is included in routine handover to the receiving hospital. The trial tests whether adding early biomarker data improves triage decisions, reduces time to reperfusion (FMC-to-balloon), and optimizes use of hospital resources. An interim analysis is planned after enrollment of 150 patients and the study is approved by the Swedish Ethical Review Authority.
Why it matters
Potential benefit: If successful, this approach could help paramedics detect more heart attacks before hospital arrival and shorten time to appropriate treatment.
How similar studies have gone: Point-of-care troponin testing and hospital-based high-sensitivity assays have shown promise for faster diagnosis, but randomized prehospital trials of high-sensitivity POC troponin remain limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Ambulance care in greater Stockholm Ltd. (AISAB)
Stockholm, Årsta, Sweden Recruiting
Study contacts
- Principal investigator: Jakob Lederman, PhD — Karolinska Institute, Department of Clinical Science and Education
- Study coordinator: Jakob Lederman, PhD
- Email: jakob.lederman@ki.se
- Phone: 0812313189
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.