NCT07092904

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 30, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

July 30, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

April 8, 2025

Last Update Submit

July 21, 2025

Conditions

Keywords

Acute myocardial infarctionPharmacoinvasiveReperfusion therapyEmergency medicinePrehospital thrombolysisprimary PCI

Outcome Measures

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.

    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.

Study Arms (1)

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

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patient declines use of data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital North Norway

Tromsø, Norway

Location

Related Publications (5)

  • 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.

    PMID: 38367969BACKGROUND
  • The Norwegian Registry for Myocardial Infarction. Annual Report for 2023. https://www.kvalitetsregistre.no/sites/default/files/2024-06/Årsrapport%202023_Norsk%20hjert

    BACKGROUND
  • 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)

    BACKGROUND
  • 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.

    PMID: 36203049BACKGROUND
  • 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.

    PMID: 29256635BACKGROUND

MeSH Terms

Conditions

Infarction

Condition Hierarchy (Ancestors)

IschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Kristian Bartnes, PhD

    University hospital North Norway

    PRINCIPAL INVESTIGATOR
  • Mads F Gilbert, PhD

    University hospital North Norway

    STUDY CHAIR

Central Study Contacts

Kristian Bartnes, PhD

CONTACT

Mads F Gilbert, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2025

First Posted

July 30, 2025

Study Start

September 1, 2025

Primary Completion

March 1, 2026

Study Completion

April 30, 2026

Last Updated

July 30, 2025

Record last verified: 2025-06

Locations