Incidence, Diagnosis, Management and Outcome of Acute Mesenteric Ischemia

Study Overview
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Brief Summary
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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.

Official Title
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Incidence, Diagnosis, Management and Outcome of Acute Mesenteric Ischaemia: a Prospective, Multicentre Observational Study

Conditions
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Acute Mesenteric Ischemia

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with suspected AMI Exclusion Criteria: Age <18 years Consent declined by patient or next of kin Chronic mesenteric ischaemia without an acute event

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Confirmed AMI<br>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<br>* No intervention<br>|
| AMI suspected but not confirmed<br>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<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of AMI | Incidence of AMI in hospitalized adult patients in acute care hospitals | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 days survival of AMI | survival of patients with confirmed AMI | 30 days after admission/suspicion of AMI/study inclusion | 
| Proportion of different forms of AMI | Proportion of each form of AMI from all AMI cases | 6 months | 
| Time to diagnosis | Time from symptoms to diagnosis | through study completion, study duration 6 months | 
| Time to treatment | Time from diagnosis to treatment | through study completion, study duration 6 months | 
| Treatment | Surgery, endovascular intervention or palliation | through study completion, study duration 6 months | 
| 1 year survival | Survival of patients with AMI 1 year after diagnosis | 1 year | 
| Quality of life score | EQ-5D-5L (EuroQoL - European Quality of Life ), 5-25 points, the lower score means better outcome | 1 year |