Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2026-01-01 @ 12:21 PM
Study NCT ID:
NCT07092904
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-30
First Post:
2025-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myocardial Infarction Safe Emergency Medicine Accompanying Study: Providing Reperfusion Therapy Within the Recommended Time Limits
Sponsor:
University Hospital of North Norway
Organization:
Study Overview
Official Title:
iTide 2 - STEMI Follow-up Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: