Incidence, Diagnosis, Management and Outcome of Acute Mesenteric Ischemia

NCT05218863 | Completed

• 1 other identifier: AMESI Study
• Study Type: observational
• Target: 709
• Locations: 2 countries
• Sites: 3

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.

Conditions

Acute Mesenteric Ischemia

Outcome Measures

Primary Outcomes (1)

• Incidence of AMI

  Incidence of AMI in hospitalized adult patients in acute care hospitals

  6 months

Secondary Outcomes (7)

• 30 days survival of AMI

  30 days after admission/suspicion of AMI/study inclusion

• Proportion of different forms of AMI

  6 months

• Time to diagnosis

  through study completion, study duration 6 months

• Time to treatment

  through study completion, study duration 6 months

• Treatment

  through study completion, study duration 6 months

Study Arms (2)

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

No intervention OTHER

No intervention

AMI suspected but not confirmed; Confirmed AMI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• All patients with suspected AMI

You may not qualify if:

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

Sponsors & Collaborators

• University of Tartu: lead

Study Sites (3)

North Estonian Regional Hospital

Tallinn, Estonia

Location

Tartu University Hospital

Tartu, Estonia

Location

Kantonsspital Luzern

Lucerne, Switzerland

Location

Related Publications (2)

• Acosta S, Blaser AR, Nuzzo A, Soltanzadeh-Naderi Y, Starkopf J, Forbes A, Murruste M, Tamme K, Voomets AL, Koitmae M, Bala M, Bodnar Z, Casian D, Demetrashvili Z, Biloslavo A, Munoz-Cruzado VD, Hess B, Kase K, Kirov M, Lindner M, Loudet CI, Damaskos D, Bjorck M; AMESI Investigators (Collaborators). D-Dimer in Acute Mesenteric Venous Thrombosis: A Prospective Case-Control International Multicenter Study. Biomark Insights. 2024 Nov 26;19:11772719241296631. doi: 10.1177/11772719241296631. eCollection 2024.

  PMID: 39600492 DERIVED

• Reintam Blaser A, Mandul M, Bjorck M, Acosta S, Bala M, Bodnar Z, Casian D, Demetrashvili Z, D'Oria M, Duran Munoz-Cruzado V, Forbes A, Fuglseth H, Hellerman Itzhaki M, Hess B, Kase K, Kirov M, Lein K, Lindner M, Loudet CI, Mole DJ, Murruste M, Nuzzo A, Saar S, Scheiterle M, Starkopf J, Talving P, Voomets AL, Voon KKT, Yunus MA, Tamme K; AMESI Investigators (Collaborators). Incidence, diagnosis, management and outcome of acute mesenteric ischaemia: a prospective, multicentre observational study (AMESI Study). Crit Care. 2024 Jan 23;28(1):32. doi: 10.1186/s13054-024-04807-4.

  PMID: 38263058 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A/Professor

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: February 1, 2022
• Study Start: June 6, 2022
• Primary Completion: April 5, 2023
• Study Completion: April 5, 2023
• Last Updated: May 31, 2023

Record last verified: 2023-05

Locations

ES (2); CH (1)