Incidence, Diagnosis, Management and Outcome of Acute Mesenteric Ischemia

Completed

• Conditions: Acute Mesenteric Ischemia
• Interventions: Other: No intervention

• Registration Number: NCT05218863
• Lead Sponsor: University of Tartu

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-04
• Study First Submitted QC: 2022-01-19
• Study First Posted: 2022-02-01
• Study Start: 2022-06-06
• Primary Completion: 2023-04-05
• Study Completion: 2023-04-05
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-29
• Last Update Posted: 2023-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 709

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AMI suspected but not confirmed	No intervention	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.
Confirmed AMI	No intervention	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.

Primary Outcome Measures

Name	Time	Method
Incidence of AMI	6 months	Incidence of AMI in hospitalized adult patients in acute care hospitals

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Tartu University Hospital; 🇪🇪 Tartu, Estonia

Kantonsspital Luzern; 🇨🇭 Luzern, Switzerland

North Estonian Regional Hospital; 🇪🇪 Tallinn, Estonia