Clinical trial NCT05218863: Incidence, Diagnosis, Management and Outcome of Acute Mesenteric Ischemia
Official title: Incidence, Diagnosis, Management and Outcome of Acute Mesenteric Ischaemia: a Prospective, Multicentre Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Mesenteric Ischemia
Lead sponsor: University of Tartu
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 709
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of AMI
timeFrame: 6 months
Secondary outcomes:
measure: 30 days survival of AMI
timeFrame: 30 days after admission/suspicion of AMI/study inclusion
measure: Proportion of different forms of AMI
timeFrame: 6 months
measure: Time to diagnosis
timeFrame: through study completion, study duration 6 months
measure: Time to treatment
timeFrame: through study completion, study duration 6 months
measure: Treatment
timeFrame: through study completion, study duration 6 months
measure: 1 year survival
timeFrame: 1 year
measure: Quality of life score
timeFrame: 1 year
Other outcomes:
Locations:
city: Tallinn
country: Estonia
facility: North Estonian Regional Hospital
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Luzern
country: Switzerland
facility: Kantonsspital Luzern
Study officials:
References: