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CompletedNCT07092904Updated Nov 9, 2026

Myocardial Infarction Safe Emergency Medicine Accompanying Study: Providing Reperfusion Therapy Within the Recommended Time Limits

An observational study in Infarction, sponsored by University Hospital of North Norway. Completed at 1 site in Norway. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by University Hospital of North Norway · Observational

Updated Nov 9, 2026Now CompletedStart date moved+3 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
148
Sex
All
01

Study summary

The project is a prospective observational study with the aim of system improvement. It represents accompanying research in connection with the implementation of Safe Emergency Medicine , - an initiative under the auspices of the board of The North Norway Regional Health Authority and The Municipal Health Consortium that aims to provide faster and better treatment to patients with common, serious and time-critical conditions.

The focus of the study is the decision-making process and implementation of treatment algorithms for all patients with acute ST-elevation myocardial infarction (STEMI) in the regional health trust's admission area. The data sources are 1) structured telephone interviews with providers and decision-makers and 2) electronic medical records (AMIS, DIPS, prehospital medical records from emergency departments, ambulance medical records). The analyses will form the basis for recommendations for improvements in procedures, training and organization.

Read the detailed description

STEMI Follow-up Study. Project Plan

Project manager Senior consultant prof. Kristian Bartnes, The Division of Cardiothoracic and Pulmonary Medicine, the University Hospital North Norway (UNN) and UiT The Arctic University of Norway

Team members Senior consultant prof. Mads Gilbert, The Division of Emergency Medicine, UNN and UiT The Arctic University of Norway Senior consultant Jan Mannsverk, Department of Cardiology, UNN Student of medicine Maryam Amri, UNN and UiT The Arctic University of Norway Project manager Safe Emergency Medicine Stein-G. Widding, UNN

Project summary The project is a prospective observational study with the aim of system improvement. It represents accompanying research in connection with the implementation of Safe Emergency Medicine , - an initiative under the auspices of the board of The North Norway Regional Health Authority and The Municipal Health Consortium that aims to provide faster and better treatment to patients with common, serious and time-critical conditions.

The study focuses on the decision-making process and implementation of treatment algorithms for all patients with acute ST-elevation myocardial infarction (STEMI) in the regional health trust's admission area. The data sources are 1) structured telephone interviews with providers and decision-makers and 2) electronic medical records (AMIS, DIPS, prehospital medical records from emergency departments, ambulance medical records). The analyses will form the basis for recommendations for improvements in procedures, training and organization.

Purpose The primary goal is to improve emergency care so that more patients survive STEMI with preserved cardiac function.

Quality improvement \< 50% of STEMI patients in Northern Norway receive reperfusion treatment (thrombolysis or primary PCI) within the recommended time intervals (2023: Northern Norway 45%, the country as a whole 69%) . Previous studies and registry data3 have identified several targets for improvement efforts: i) more efficient on-site workflow, ii) faster and more precise communication among the emergency care providers, iii) more efficient decision-making, iv) competence enhancement.

Patient safety Loss of time leads to loss of myocardium and in some cases death, or survival with chronic heart failure.

Generalization value Improving quality for one patient category will also benefit other categories within the same treatment system. And extensive, resource-intensive initiatives should be evaluated and adjusted accordingly.

Safe emergency medicine aims to provide faster and better treatment of patients with common, serious emergency medical conditions (heart attack, stroke, sepsis) with. The initiative is backed by the board of The Regional Health Trust and The Municipal Health Consortium and is being gradually implemented throughout the region. The current project is an accompanying research-initiative aimed at one of the relevant patient categories. Other categories with time-critical conditions will benefit from the experiences we gain from the STEMI segment, since they depend on the same system.

Material/method Inclusion All patients with a diagnosis of acute STEMI in the catchment area of The North Norway Regional Health Authority's hospitals in the period approx. May 1st - October 31st 2025.

Privacy and ethics The protocol is submitted to the hospital's data protection officer and the Regional Ethics Committee for approval.

Parameters Patient data Clinical course for 1 month from onset, with exact time intervals and description of interventions and treatment results. Data are collected from electronic sources (AMIS, emergency room physician's notes, ambulance records, air ambulance records, DIPS, MetaVision, diagnostic imaging systems).

Decision-making process For all patients, the agencies involved in communication and decisions about treatment modality and location are described, from the first contact with the health service until the start of reperfusion therapy (or decision to forgo it). Effective and consistent use of multi-party conversation has been identified as a critical vulnerability and will be given special emphasis in the analysis.

Time spent, form of communication (emergency network radio, telephone, multi-party call or sequential, etc.) are recorded.

Data are collected through structured telephone interviews with therapists and decision-makers within 2 days of patient inclusion, based on a self-developed template.

Analyses Statistical analyses of categorical and continuous variables are performed using electronic tools (SPSS, Excel), including time-to-event and regression analyses.

Statistical strength A 40% improvement for the primary endpoint from 2021 to 2025 would be significant at the 5% level.

Primary endpoint Proportion of STEMI patients who receive reperfusion therapy within the recommended time.

Secondary endpoints Extent of aim achievement (proportion of patients within the recommended time interval) for process indicators in the acute course of STEMI: time from first medical contact to i) ECG recording, ii) STEMI diagnosis, iii) treatment decision.

Degree of compliance with time intervals described in Safe Emergency Medicine and guidelines for prehospital communication.

Dissemination/publication of results The results will be published in a scientific journal and used in a master's thesis for medical student(s), shared at professional meetings and included in improvement work within the framework of the regional Safe Acute Medicine project.

02

Conditions studied

  • Infarction

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Keywords

  • Acute myocardial infarction
  • Pharmacoinvasive
  • Reperfusion therapy
  • Emergency medicine
  • Prehospital thrombolysis
  • primary PCI
03

In context

Infarction

71 studies on the registry are indexed under Infarction; 15 are open to participants now.

This study's enrollment of 148 is above the median of 119 across 23 observational studies indexed under Infarction.

Browse Infarction studies →

Lead sponsor

University Hospital of North Norway is the lead sponsor of 152 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients diagnosed with acute ST elevation myocardial infarction within the municipalities of Nordland, Troms and Finnmark.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient with the diagnosis of acute ST elevation myocardial infarction located within the uptake area of the Northern Norway Regional Health Authority

Exclusion criteria

Exclusion Criteria:

  • Patient declines use of data
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
148 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with acute ST elevation myocardial infarction in our region, all-comers

    The patients are not subjected to any intervention for the study purpose.

06

What researchers measure

Primary outcomes

  1. Proportion of patients with acute ST elevation myocardial infarction who receive reperfusion therapy within the recommended time intervals.

    Internationally approved guidelines provide clear, evidence-based time interval recommendations for receiveing rapid reperfusion therapy, either by fibrinolytic medication or primary percutaneous coronary intervention. The primary endpoint adresses the extent of aim fulfillment.

    Time frame: Inclusion will be performed during 6 months from September 1st 2025 - March 1st 2026. Each patient will be monitored for 1 month after enrollment (baseline). The interval from the diagnostic ECG recording to reperfusion therapy initiation is reported.

07

Study locations

1 site
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References and documents

Publications

  • Uleberg B, Bonaa KH, Govatsmark RES, Olsen F, Jacobsen BK, Stensland E, Hauglann B, Vonen B, Forde OH. Exploring variation in timely reperfusion treatment in ST-segment elevation myocardial infarction in Norway: a national register-based cohort study. BMJ Open. 2024 Feb 17;14(2):e081301. doi: 10.1136/bmjopen-2023-081301. PubMed 38367969 ↗
  • The Norwegian Registry for Myocardial Infarction. Annual Report for 2023. https://www.kvalitetsregistre.no/sites/default/files/2024-06/Årsrapport%202023_Norsk%20hjert
  • Hansen, AS (2021). Treatment and outcome for patients with ST-elevation myocardial infarction in Norway. Are there differences in the management and outcome of STEMI within Norway and compared to other Nordic countries? (Master's thesis, UiT Arctic University of Norway)
  • Bartnes K, Albrigtsen H, Iversen JM, Brovold H, Moller NH, Wembstad B, Arstad F, Kristensen AH, Cortis J, Olsen SJ, Nygaard SNS, Kindler SG, Moe O, Hansen C, Mannsverk JT. The Barriers to Rapid Reperfusion in Acute ST-Elevation Myocardial Infarction. Cardiol Ther. 2022 Dec;11(4):559-574. doi: 10.1007/s40119-022-00281-7. Epub 2022 Oct 6. PubMed 36203049 ↗
  • Mannsverk J, Steigen T, Wang H, Tande PM, Dahle BM, Nedrejord ML, Hokland IO, Gilbert M. Trends in clinical outcomes and survival following prehospital thrombolytic therapy given by ambulance clinicians for ST-elevation myocardial infarction in rural sub-arctic Norway. Eur Heart J Acute Cardiovasc Care. 2019 Feb;8(1):8-14. doi: 10.1177/2048872617748550. Epub 2017 Dec 19. PubMed 29256635 ↗

Individual participant data

Plan to share: Undecided

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Completed
changed Nov 9, 2026
Start date
Sep 1, 2025→Jan 1, 2026 (actual)
Nov 9, 2026
Primary completion
Mar 1, 2026→Jul 31, 2026 (actual)
Nov 9, 2026
Study completion
Apr 30, 2026→Jul 31, 2026 (actual)
Nov 9, 2026
Enrollment
200 (estimated)→148 (actual)
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    Not yet recruiting→Completed
    Start date Sep 1, 2025→Jan 1, 2026 (now actual)
    Primary completion Mar 1, 2026→Jul 31, 2026 (now actual)
    Study completion Apr 30, 2026→Jul 31, 2026 (now actual)
    Enrollment 200 (estimated)→148 (actual)
    + 4 other changes: verification date, responsible party, oversight details and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07092904
Collaborators
The Royal Norwegian Ministry of Health
Responsible party
Sponsor
First posted
Jul 30, 2025
Start date
Jan 1, 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026
Last update
Nov 9, 2026

Study contacts

Kristian Bartnes, PhD
principal investigator · University hospital North Norway
Mads F Gilbert, PhD
study chair · University hospital North Norway

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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