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InfarctionNCT07092904

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

An observational study of Infarction, run by University Hospital of North Norway at 1 site in Norway.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Infarction
How many people
200 participants
Where
1 siteNorway
Study dates
1 Sep 2025to 30 Apr 2026
Phase
Observational
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Patient declines use of data

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kristian Bartnes, PhD contact

+4797063364

kristian.bartnes@unn.no

Mads F Gilbert, PhD contact

+4790878740

mads.gilbert@gmail.com

Norway1 site
  • University hospital North Norway

    Tromsø

    Kristian Bartnes, PhD, +4777626000, kristian.bartnes@unn.no

    Mads F Gilbert, PhD, +4790878740, mads.gilbert@gmail.com

Other trials in Norway

About this study

Official title: iTide 2 - STEMI Follow-up Study

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.

Conditions
Infarction
Keywords
Acute myocardial infarction, Pharmacoinvasive, Reperfusion therapy, Emergency medicine, Prehospital thrombolysis, primary PCI
Medical subject headings
Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07092904
Study groupRoleWhat they receive
Patients with acute ST elevation myocardial infarction in our region, all-comersThe patients are not subjected to any intervention for the study purpose.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2025
  2. Study start1 Sep 2025 (estimated)
  3. Primary completion1 Mar 2026 (estimated)
  4. Study completion30 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07092904
Sponsor's protocol ID
904338
Status last verified
Jun 2025
First submitted
8 Apr 2025
Last updated
30 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

An observational study of Infarction, run by University Hospital of North Norway at 1 site in Norway.

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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 30 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 Norway. 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 Kristian Bartnes, PhD (+4797063364, kristian.bartnes@unn.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with acute ST elevation myocardial infarction who receive reperfusion therapy within the recommended time intervals. (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07092904, which also lists 5 linked publications.

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 30 Jul 2025.

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