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RecruitingNCT06445660AMESIradiolUpdated Mar 25, 2025

The Feasibility of a Radiological Score Based on CT Signs for Recognizing Salvageable Bowel in Acute Mesenteric Ischemia

An observational study in Acute Mesenteric Ischemia, sponsored by University of Tartu. Recruiting at 1 site in Estonia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-25.

Sponsored by University of Tartu · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Acute Mesenteric Ischemia
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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

Exclusion Criteria:

  • Scans without the use of an intravenous contrast media or those covering only a partial area of the abdomen will be excluded.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • 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: 1. treated endovascularly and did not undergo bowel resection secondarily 2. received surgical revascularization without bowel resection (initial or secondary) 3. received explorative laparoscopy or laparotomy without the need for bowel resection (initially or secondarily) 4. 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): 1. underwent bowel resection initially 2. underwent bowel resection secondarily 3. did not undergo bowel resection because non-salvageable bowel 4. were changed to palliation due to the progression of ischaemia after any initial treatment with curative intention (including endovascular and conservative)

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What researchers measure

Primary outcomes

  1. Frequency rate

    Frequency rate of common radiological signs in AMI patients with and without salvageable bowel.

    Time frame: up to one month

Secondary outcomes

  1. Performance of the radiological score

    Performance of the radiological score in patients with different types of AMI.

    Time frame: up to one month

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Study locations

1 of 1 sites recruiting
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References and documents

Study documents

  • Study protocol · Jan 3, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

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Registry details

Key details

Study ID
NCT06445660
Lead sponsor
University of Tartu
Responsible party
Annika Reintam Blaser (associate professor, University of Tartu) — Principal investigator
First posted
Jun 6, 2024
Start date
Jun 6, 2022
Primary completion
Apr 5, 2023
Completion
May 31, 2025 (estimated)
Last update
Mar 25, 2025

Study contacts

Joel Starkopf
Contact
joel.starkopf@ut.ee
53318400 ext. 372
Kätlin Eiche
Contact
Katlin.Eiche@ut.ee
Joel Starkopf
study chair · University of Tartu, Department of Anaesthesiology and Intensive Care

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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