Incidence, Diagnosis, Management and Outcome of Acute Mesenteric Ischemia

Acute Mesenteric Ischemia Clinical Trial

— AMESI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05218863
• Other study ID #: AMESI Study
• Status: Completed
• Start date: June 6, 2022
• Est. completion date: April 5, 2023

Study information

• Verified date: May 2023
• Source: University of Tartu
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 709
• Est. completion date: April 5, 2023
• Est. primary completion date: April 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Mesenteric Ischemia
• Ischemia
• Mesenteric Ischemia

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Estonia	North Estonian Regional Hospital	Tallinn
Estonia	Tartu University Hospital	Tartu
Switzerland	Kantonsspital Luzern	Luzern

Sponsors (1)

Lead Sponsor	Collaborator
University of Tartu

Countries where clinical trial is conducted

Estonia,  Switzerland, 

Outcome

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