Incidence, Diagnosis, Management and Outcome of Acute Mesenteric Ischemia (AMESI)

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Mesenteric Ischemia
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 709

Contacts and Locations

• Study Contact: Name: Annika Reintam Blaser, PhD; Phone Number: +372731 8405; Email: annika.reintam.blaser@ut.ee

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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; No intervention

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Tartu

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: January 19, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 29, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

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

Drug and device information, study documents

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