The Feasibility of a Radiological Score Based on CT Signs for Recognizing Salvageable Bowel in Acute Mesenteric Ischemia (AMESIradiol)
The Feasibility of a Radiological Score Based on Quantified Analysis of Computed Tomography Signs for Recognizing Salvageable Bowel in Acute Mesenteric Ischemia: A Retrospective Analysis of Prospective Study
Computed tomography (CT) is the standard modality for scanning patients with critical acute abdominal conditions, including suspected acute mesenteric ischemia (AMI). CT imaging can potentially differentiate between reversible and irreversible ischaemic damage of the bowel. This moment is pivotal in selecting the treatment strategy for AMI - in the absence of irreversible damage; reperfusion therapy can preserve intestinal viability, thereby avoiding the need for bowel resection. The present study tests the hypothesis that combining several symptoms may enhance the diagnostic performance of CT scanning in detecting salvageable bowel in patients with AMI. This study is an ancillary component of the AMESI study (Clinical Trials: NCT05218863) - a prospective, multicentre observational study aimed at identifying the incidence and describing the outcomes of acute mesenteric ischemia (AMI) in adult hospitalized patients. The ultimate purpose of the present study is to create a computed tomography-based radiological score for the assessment of bowel viability in patients with AMI.
Study Overview
Status
Status
Conditions
Conditions
Study Type
Study Type
Enrollment (Actual)
Enrollment
Contacts and Locations
Study Locations
-
-
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Tartu, Estonia, 50408
- Tartu University Hospital
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
This is a substudy of the AMESI study - "Incidence, Diagnosis, Management, and Outcome of Acute Mesenteric Ischaemia: A Prospective, Multicentre Observational Study." (Clinical Trials: NCT05218863) As of the end of August 2023, a total of 705 patients from 32 study sites worldwide have been enrolled, with 418 of them having confirmed cases of AMI. For patients with confirmed AMI, comprehensive data collection concerning diagnostics, management, and long-term outcomes has been completed
Description
Inclusion Criteria:
- Participant in AMESI study
- confirmed or suspected acute mesenteric ischaemia
- CT scan of the entire abdominal cavity / full body using intravenous contrast media is available
Exclusion Criteria:
- Scans without the use of an intravenous contrast media or those covering only a partial area of the abdomen will be excluded.
Study Plan
How is the study designed?
Design Details
- Observational Models: COHORT
- Time Perspectives: PROSPECTIVE
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
|---|
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Controls
Patients included in the AMESI study as suspected AMI |
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AMI patients with salvageable bowel
Patients included in the AMESI study with confirmed AMI, who did not undergo bowel resection Patients with one of the following:
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AMI patients with non-salvageable bowel
Patients included in the AMESI study with confirmed AMI who (one of the following):
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency rate
Time Frame: up to one month
|
Frequency rate of common radiological signs in AMI patients with and without salvageable bowel. |
up to one month
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Performance of the radiological score
Time Frame: up to one month
|
Performance of the radiological score in patients with different types of AMI. |
up to one month
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Chair: Joel Starkopf, University of Tartu, Department of Anaesthesiology and Intensive Care
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- 03.01.2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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