Actively Recruiting
High-Sensitivity Troponin I in Addition to Guideline-Based Care in Emergency Medical Service - an Open Randomized Controlled Trial
Led by Karolinska Institutet · Updated on 2025-07-02
1419
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
K
Karolinska Institutet
Lead Sponsor
R
Region Stockholm
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of a high-sensitivity Troponin I blood test in emergency medical services (EMS) to improve early detection of heart attacks in patients with chest pain or suspected myocardial infarction. This randomized controlled trial compares the addition of this quick test to standard guideline-based care during ambulance transport in Stockholm, Sweden. The study aims to see if early biomarker testing can speed up diagnosis and treatment, potentially improving patient outcomes. Participants are randomly assigned in a 2:1 ratio to receive either standard EMS care plus the point-of-care Troponin I test using the Siemens Atellica4 VTLi system or standard care alone. The Troponin test result is available in real-time to EMS providers and communicated to the hospital during handover. The study includes safety monitoring with an interim analysis after 150 patients and plans to enroll about 1,419 adults. During the study, participants will receive emergency care according to their assigned group. Researchers will measure the time from first medical contact to vascular access during PCI, as well as other time intervals such as to ECG and emergency department admission. They will also track hospital length of stay, major cardiac events, intervention frequency, and diagnostic accuracy of the Troponin test. The study lasts through the hospital stay and includes follow-up at 30 days to assess outcomes and safety.
CONDITIONS
Brief Title
High-Sensitivity Troponin I in Addition to Guideline-Based Care in EMS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chest pain or discomfort and/or clinical suspicion of myocardial infarction by the prehospital personnel
- Age 18 years or older
You will not qualify if you...
- Patients suffering from trauma and conveyed to a level 1 trauma hospital
- Missing valid social security number
- Unable to give informed consent
- Not a primary emergency assignment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - Single EMS care episode during emergency presentation
Participants receive prehospital high-sensitivity Troponin I testing in addition to standard guideline-based care as part of emergency medical service (EMS) assessment.
1 visit (in-person EMS assessment)
Duration - Up to 30 days after first medical contact
Participants are monitored for clinical outcomes including major adverse cardiovascular events and other time-critical medical conditions after initial EMS care and hospital discharge.
Follow-up assessments up to 30 days post EMS contact
Trial Site Locations
Total: 1 location
1
Ambulance care in greater Stockholm Ltd. (AISAB)
Stockholm, Årsta, Sweden, 12040
Actively Recruiting
Research Team
J
Jakob Lederman, PhD
S
Sebastian Bjöhle, Doctoral student
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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