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: Recruiting
• Conditions: Acute Mesenteric Ischemia

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Joel Starkopf; Phone Number: 372 53318400; Email: joel.starkopf@ut.ee
• Study Contact Backup: Name: Kätlin Eiche; Email: Katlin.Eiche@ut.ee

Study Locations

• Estonia
  • Tartu, Estonia, 50408
    • Recruiting
    • Tartu University Hospital
    • Contact: Martin Reim, Dr; Email: Martin.Reim@kliinikum.ee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Controls; Patients included in the AMESI study as suspected AMI
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: treated endovascularly and did not undergo bowel resection secondarily; received surgical revascularization without bowel resection (initial or secondary); received explorative laparoscopy or laparotomy without the need for bowel resection (initially or secondarily); received conservative treatment without the need for secondary bowel resection
AMI patients with non-salvageable bowel; Patients included in the AMESI study with confirmed AMI who (one of the following): underwent bowel resection initially; underwent bowel resection secondarily; did not undergo bowel resection because non-salvageable bowel; were changed to palliation due to the progression of ischaemia after any initial treatment with curative intention (including endovascular and conservative)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency rate	Frequency rate of common radiological signs in AMI patients with and without salvageable bowel.	up to one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of the radiological score	Performance of the radiological score in patients with different types of AMI.	up to one month

Collaborators and Investigators

• Sponsor: University of Tartu
• Investigators: Study Chair: Joel Starkopf, University of Tartu, Department of Anaesthesiology and Intensive Care

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2022
• Primary Completion (Actual): April 5, 2023
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: May 22, 2024
• First Submitted That Met QC Criteria: May 31, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Peritoneal Diseases; Ischemia; Mesenteric Ischemia
• Other Study ID Numbers: 03.01.2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No