- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04614805
Timely Reperfusion in Acute ST-segment Myocardial Infarction
January 4, 2023 updated by: Kristian Bartnes, University Hospital of North Norway
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
146
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Troms Og Finnmark
-
Tromsø, Troms Og Finnmark, Norway, 9038
- University Hospital North Norway
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients diagnosed with STEMI in our regional health trust during the study period who has an indication for immediate reperfusion therapy
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Reperfusion therapy not indicated or contraindicated
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
This parameter will be recorded within 1 week after patient inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ejection fraction at discharge
Time Frame: This parameter will be recorded up to 6 months after patient inclusion
|
Systolic function of the left ventricle
|
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.
|
Survival after 30 days from incident
|
This parameter will be collected from patient's records during Nov -20 till Aug -21.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2020
Primary Completion (Actual)
January 4, 2023
Study Completion (Actual)
January 4, 2023
Study Registration Dates
First Submitted
October 18, 2020
First Submitted That Met QC Criteria
October 28, 2020
First Posted (Actual)
November 4, 2020
Study Record Updates
Last Update Posted (Estimate)
January 6, 2023
Last Update Submitted That Met QC Criteria
January 4, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- iTide
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
so far no plans for such sharing.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.