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CompletedNCT05218863AMESIUpdated May 31, 2023

Incidence, Diagnosis, Management and Outcome of Acute Mesenteric Ischemia

An observational study in Acute Mesenteric Ischemia, sponsored by University of Tartu. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-31.

Sponsored by University of Tartu · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
709
Ages
18 Years and older
Sex
All
01

Study summary

This is a prospective, multicentre observational study screening all adult patients admitted to a participating hospital over a 6-month study period (may be adjusted to 4-8 months according to recruitment) and including all patients with suspicion of or confirmed acute mesenteric ischaemia (AMI).

Only admission data and hospital mortality outcome will be collected for patients in whom suspicion of AMI is not confirmed. For patients with confirmed AMI full data collection regarding diagnostics, management and long-term outcome is required.

Investigators aim to recruit 40-50 sites with expected median of 10-20 patients with confirmed AMI per site during the study period (naturally depending on the size of the hospital). The start of the study is planned for Spring 2022.

The aim of the study is to identify the incidence of AMI and its different forms in adult hospitalized patients, and to describe patient characteristics (demographic, clinical and laboratory) at baseline, applied diagnostics and management, as well as outcomes in patients with AMI. An additional aim is to compare the baseline characteristics and outcomes of patients with confirmed AMI to those of patients with suspected AMI in whom the diagnosis was not confirmed.

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Conditions studied

  • Acute Mesenteric Ischemia

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03

In context

Mesenteric Ischemia

40 studies on the registry are indexed under Mesenteric Ischemia; 14 are open to participants now.

This study's enrollment of 709 is above the median of 154 across 26 observational studies indexed under Mesenteric Ischemia.

Browse Mesenteric Ischemia studies →

Lead sponsor

University of Tartu is the lead sponsor of 46 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All adult patients admitted to a participating hospital during the study period will be screened to include all patients with suspicion of or confirmed acute mesenteric ischaemia (AMI).

All patients with suspicion of or confirmed AMI are to be included in the study in accordance with local ethics requirements:

  • If suspicion of AMI is NOT confirmed, only baseline data and hospital mortality outcome is collected
  • if the diagnosis of AMI is confirmed, then full data collection is required

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

All patients with suspected AMI

Exclusion criteria

Exclusion Criteria:

Age \<18 years Consent declined by patient or next of kin Chronic mesenteric ischaemia without an acute event

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
709 participants (actual)
Patient registry
No

Groups and cohorts

  • Confirmed AMI

    Patients in whom diagnosis of acute mesenteric ischaemia (AMI) was confirmed. For these patients full data collection is required, including 1-year outcome. Maximum 500 patients in this group.

    Other: No intervention

  • AMI suspected but not confirmed

    Patients in whom acute mesenteric ischaemia (AMI) was suspected but not confirmed. For these patients minimal data will be collected, only hospital survival as outcome. Maximum 2000 patients in this group.

    Other: No intervention

Interventions

  • OtherNo intervention

    No intervention

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What researchers measure

Primary outcomes

  1. Incidence of AMI

    Incidence of AMI in hospitalized adult patients in acute care hospitals

    Time frame: 6 months

Secondary outcomes

  1. 30 days survival of AMI

    survival of patients with confirmed AMI

    Time frame: 30 days after admission/suspicion of AMI/study inclusion

  2. Proportion of different forms of AMI

    Proportion of each form of AMI from all AMI cases

    Time frame: 6 months

  3. Time to diagnosis

    Time from symptoms to diagnosis

    Time frame: through study completion, study duration 6 months

  4. Time to treatment

    Time from diagnosis to treatment

    Time frame: through study completion, study duration 6 months

  5. Treatment

    Surgery, endovascular intervention or palliation

    Time frame: through study completion, study duration 6 months

  6. 1 year survival

    Survival of patients with AMI 1 year after diagnosis

    Time frame: 1 year

  7. Quality of life score

    EQ-5D-5L (EuroQoL - European Quality of Life ), 5-25 points, the lower score means better outcome

    Time frame: 1 year

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Study locations

3 sites
  • North Estonian Regional Hospital
    Tallinn, Estonia
  • Tartu University Hospital
    Tartu, Estonia
  • Kantonsspital Luzern
    Luzern, Switzerland
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05218863
Lead sponsor
University of Tartu
Responsible party
Annika Reintam Blaser (A/Professor, University of Tartu) — Principal investigator
First posted
Feb 1, 2022
Start date
Jun 6, 2022
Primary completion
Apr 5, 2023
Completion
Apr 5, 2023
Last update
May 31, 2023

Oversight

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

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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