AMESI - Mesenteric ischaemia - Prospective observational study
Research type
Research Study
Full title
Incidence, diagnosis, management and outcome of Acute MESenteric Ischaemia: a prospective, multicentre observational study (AMESI Study)
IRAS ID
314494
Contact name
Annika Reintam Blaser
Contact email
Sponsor organisation
University of Tartu
Clinicaltrials.gov Identifier
Approval: 3571T-8, Research Ethics Committee of the University of Tartu (UT REC)
Duration of Study in the UK
1 years, 1 months, 30 days
Research summary
Acute mesenteric ischaemia (AMI) is a life-threatening painful condition where the blood supply to the bowel is blocked, usually due to a blood clot or blood vessel disease. It is a surgical and medical emergency, and is not well studied to date.
The aim of this study is to collect and analyse data from people who are suspected to be experiencing AMI, and also gather information about their outcomes afterwards.
Synopsis
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).
For patients with confirmed AMI full data collection regarding diagnostics, management and long-term outcome is required (see Figure 1 and 2). For patients in whom AMI was suspected but subsequently excluded, only baseline data and hospital mortality outcome will be collected.
We aim to include patients from 40-50 hospitals from approximately 25-30 countries worldwide and expect an average 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 May 2022.
The aim of the study is to identify the incidence of AMI and its different forms in adult hospitalized patients at any time during their hospital admission, and to describe patient characteristics (demographic, clinical and laboratory data) at baseline, applied diagnostics and management, as well as outcomes in patients with AMI. Additionally, we aim 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.We will share the outcome of our project at academic meetings and in published papers.
REC name
London - South East Research Ethics Committee
REC reference
22/LO/0399
Date of REC Opinion
22 Aug 2022
REC opinion
Further Information Favourable Opinion