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.
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.
Norway1 site
University hospital North Norway
Tromsø
Kristian Bartnes, PhD, +4777626000, kristian.bartnes@unn.no
Mads F Gilbert, PhD, +4790878740, mads.gilbert@gmail.com
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 group | Role | What they receive |
|---|---|---|
| Patients with acute ST elevation myocardial infarction in our region, all-comers | The 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.
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.
- First posted30 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristian Bartnes, PhD, Principal investigator, University hospital North NorwayMads F Gilbert, PhD, Study chair, University hospital North Norway
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 38367969The 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 36203049Mannsverk 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iTide 2 - STEMI Follow-up Study
- ClinicalTrials.gov ID
- NCT07092904
- Acronym / sponsor ID
- 904338
- Conditions
- Infarction
- Keywords
- Acute myocardial infarction, Pharmacoinvasive, Reperfusion therapy, Emergency medicine, Prehospital thrombolysis, primary PCI
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute ST elevation myocardial infarction in our region, all-comers | – | –The patients are not subjected to any intervention for the study purpose. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with acute ST elevation myocardial infarction within the municipalities of Nordland, Troms and Finnmark.
Key inclusion criteria (1 listed)
- Patient with the diagnosis of acute ST elevation myocardial infarction located within the uptake area of the Northern Norway Regional Health Authority
Key exclusion criteria (1 listed)
- Patient declines use of data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Background: PubMed 38367969Uleberg 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.
- BackgroundThe Norwegian Registry for Myocardial Infarction. Annual Report for 2023. https://www.kvalitetsregistre.no/sites/default/files/2024-06/Årsrapport%202023_Norsk%20hjert
- BackgroundHansen, 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: PubMed 36203049Bartnes 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.
- Background: PubMed 29256635Mannsverk 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristian Bartnes, PhD principal investigator
University hospital North Norway
Mads F Gilbert, PhD study chair
University hospital North Norway
1 site in 1 country: see every site and its status.
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.