Acute Myocardial InfarctionNCT04614805
Timely Reperfusion in Acute ST-segment Myocardial Infarction
An observational study of Acute Myocardial Infarction, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
The aim of the study is to monitor outcomes, especially time to reperfusion, in ST-elevation acute myocardial infarction patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Mobilizing clinical leaders
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 146 participants
- Where
- 1 siteNorway
- Study dates
- 1 Nov 2020to 4 Jan 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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: All patients diagnosed with STEMI in our regional health trust during the study period who has an indication for immediate reperfusion therapy
Who may be able to join
- Patient diagnosed with acute myocardial infarction with ST-elevations within our regional health trust during Nov 1st and for approx 4 months, and with an indication for reperfusion therapy (thrombolysis and/pr PCI)
Who cannot join
- Reperfusion therapy not indicated or contraindicated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mobilizing Clinical Leadership to Achieve Timely Reperfusion in Acute ST-segment Elevation Myocardial Infarction
The aim of the study is to monitor outcomes, especially time to reperfusion, in ST-elevation acute myocardial infarction patients.
Read the detailed description
In the regional health trust of North Norway, time to reperfusion in acute ST-elevation myocardial infarction is below the national average and below recommendations. The aim of this study is to monitor outcomes, especially time to reperfusion, in ST-elevation acute myocardial infarction patients. The study period is supposedly lasting for approximately 4 months, the time estimated to observe the clinical course of 100 patients. Before and during the study period, clinical leaders are encouraged to improve guideline adherence and to closely monitor the results of their own and collaborating institutions.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Mobilizing clinical leaders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobilizing clinical leadersBehavioural
Clinical leaders and clinical personnel will regularly receive feedback regarding performance of their own hospital as well as other providers in the regional health trust of North Norway.
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to reperfusion
Interval between 1st medical contact and opening of the infarction-related coronary artery.
Measured: This parameter will be recorded within 1 week after patient inclusion
Secondary outcomes (2)
Ejection fraction at discharge
Systolic function of the left ventricle
Measured: This parameter will be recorded up to 6 months after patient inclusion
Survival
Survival after 30 days from incident
Measured: This parameter will be collected from patient's records during Nov -20 till Aug -21.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start1 Nov 2020
- Primary completion4 Jan 2023
- Study completion4 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial 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
- 146 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristian Bartnes, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614805
- Sponsor's protocol ID
- iTide
- Status last verified
- Jan 2023
- First submitted
- 18 Oct 2020
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: so far no plans for such sharing.
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobilizing Clinical Leadership to Achieve Timely Reperfusion in Acute ST-segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT04614805
- Acronym / sponsor ID
- iTide
- Conditions
- Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 4 Jan 2023 (actual)
- Study completion
- 4 Jan 2023 (actual)
- First posted
- 4 Nov 2020 (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 aim of the study is to monitor outcomes, especially time to reperfusion, in ST-elevation acute myocardial infarction patients.
Detailed description
In the regional health trust of North Norway, time to reperfusion in acute ST-elevation myocardial infarction is below the national average and below recommendations. The aim of this study is to monitor outcomes, especially time to reperfusion, in ST-elevation acute myocardial infarction patients. The study period is supposedly lasting for approximately 4 months, the time estimated to observe the clinical course of 100 patients. Before and during the study period, clinical leaders are encouraged to improve guideline adherence and to closely monitor the results of their own and collaborating institutions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients diagnosed with STEMI in our regional health trust during the study period who has an indication for immediate reperfusion therapy
Key inclusion criteria (1 listed)
- Patient diagnosed with acute myocardial infarction with ST-elevations within our regional health trust during Nov 1st and for approx 4 months, and with an indication for reperfusion therapy (thrombolysis and/pr PCI)
Key exclusion criteria (1 listed)
- Reperfusion therapy not indicated or contraindicated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobilizing clinical leadersClinical leaders and clinical personnel will regularly receive feedback regarding performance of their own hospital as well as other providers in the regional health trust of North Norway. | Behavioural | – |
Primary outcome
Time to reperfusion
Time frame: This parameter will be recorded within 1 week after patient inclusion
Interval between 1st medical contact and opening of the infarction-related coronary artery.
2 secondary outcomes
Ejection fraction at discharge
Time frame: This parameter will be recorded up to 6 months after patient inclusion
Survival
Time frame: This parameter will be collected from patient's records during Nov -20 till Aug -21.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Derived from this study: 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.
- Individual participant dataSharing planned: Undecided. so far no plans for such sharing.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Myocardial 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: finished, as of the sponsor's last update on 6 Jan 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to reperfusion (time frame: This parameter will be recorded within 1 week after patient inclusion). 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 NCT04614805, which also lists 1 linked publication.
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 6 Jan 2023.