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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Timely Reperfusion in Acute ST-segment Myocardial Infarction

NCT04614805

Acute Myocardial Infarction

COMPLETED

Emergency Medical Services (EMS) Telehealth to Speed STEMI Reperfusion

NCT06945900

STEMI - ST Elevation Myocardial Infarction

RECRUITING

Postconditioning in ST-elevation Myocardial Infarction

NCT00922675

Myocardial Infarction

COMPLETED NA

Sonothrombolysis in Patients With STEMI

NCT03092089

ST-segment Elevation Myocardial Infarction

COMPLETED PHASE2

Quality and Safety of Initial Management for ST-segment Elevation Myocardial Infarction

NCT02788344

Myocardial Infarction

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Infarction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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