- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07274306
Incidence, Treatment and Outcome After Acute Mesenteric Ischemia in the Region of Västra Götaland, 2000-2023. (AMIGO)
Incidence, Treatment of and Outcome of Acute Mesenteric Ischemia in the Region of Västra Götaland, 2000-2023 - a Retrospective Observational Study
The goal of this retrospective observational study is to describe the incidence and outcome of patients diagnosed with acute mesenteric ischemia (AMI) in the Västra Götaland region of Sweden between 2000-2023. The main questions it aims to answer are:
- What was the observed incidence and outcome, and how did it change during the time period?
- How did socioeconomic factors influence incidence and outcome of AMI?
- What main surgical approaches were selected for these patients?
- What was the distribution of anticoagulant use in the cohort, and what effect did the introduction of new oral anticoagulants (NOAC) have on incidence and mortality in AMI?
- What was the prevalence of Short Bowel Syndrome (SBS) after surgical intervention?
Participants were obtained from the regional diagnosis registry. Additional datapoints were obtained from the Swedish statistics bureau and pharmaceutical registers.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Gothenburg, Sweden
- Sahlgrenska University Hospital
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Västra Götaland County
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Gothenburg, Västra Götaland County, Sweden, 41685
- Sahlgrenska hospital/Östra hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- all patients discharged from hospital with acute mesenteric ischemia (ICD K55.0 and K55.9)
Exclusion Criteria:
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Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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VG Region patients with AMI diagnosis 2000-2023
A cohort of all patients who were discharged with the diagnosis acute mesenteric ischemia (ICD-10: K55.0 or K55.9) in the Västra Götaland region of Sweden between 2000-01-01 and 2023-12-31.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incidence of acute mesenteric ischemia
Time Frame: Year 2000-2023
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Annual incidence rate of acute mesenteric ischemia per 100,000 person-years in the Västra Götaland region.
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Year 2000-2023
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Mortality from acute mesenteric ischemia
Time Frame: 30 days, 90 days, 1 year.
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All-cause mortality within up to 1 year of AMI diagnosis.
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30 days, 90 days, 1 year.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Temporal trends in incidence and mortality
Time Frame: Year 2000-2023
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Change over time in incidence and mortality, including before and after introduction of non-vitamin K antagonist oral anticoagulants (NOACs).
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Year 2000-2023
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Socioeconomic determinants of incidence and outcome
Time Frame: Year 2000-2023
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Association between SES indicators (income, education, immigration status, geographic distance to care) and risk of AMI or mortality.
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Year 2000-2023
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Surgical management strategy
Time Frame: Year 2000-2023
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Proportion of patients undergoing bowel resection, revascularization (open or endovascular), or non-operative management.
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Year 2000-2023
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Prevalence of Short Bowel Syndrome (SBS)
Time Frame: Within 1 year of surgical intervention
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Number and percentage of patients developing SBS (ICD-10 K91.2 and K90.8) after AMI.
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Within 1 year of surgical intervention
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Anticoagulant use patterns
Time Frame: At AMI diagnosis; trends from 2000-2023
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Proportion of patients using vitamin-K antagonists, NOACs, antiplatelet therapy, or no anticoagulation; association with incidence and survival.
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At AMI diagnosis; trends from 2000-2023
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-04585-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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