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OpenTrials
Completed

NCT Number: NCT05218863

Incidence, Diagnosis, Management and Outcome of Acute Mesenteric Ischemia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

North Estonian Regional Hospital, Tallinn, Estonia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Incidence of AMI

    Time frame: 6 months

    Incidence of AMI in hospitalized adult patients in acute care hospitals

Secondary outcomes

  1. 30 days survival of AMI

    Time frame: 30 days after admission/suspicion of AMI/study inclusion

    survival of patients with confirmed AMI

  2. Proportion of different forms of AMI

    Time frame: 6 months

    Proportion of each form of AMI from all AMI cases

  3. Time to diagnosis

    Time frame: through study completion, study duration 6 months

    Time from symptoms to diagnosis

  4. Time to treatment

    Time frame: through study completion, study duration 6 months

    Time from diagnosis to treatment

  5. Treatment

    Time frame: through study completion, study duration 6 months

    Surgery, endovascular intervention or palliation

  6. 1 year survival

    Time frame: 1 year

    Survival of patients with AMI 1 year after diagnosis

  7. Quality of life score

    Time frame: 1 year

    EQ-5D-5L (EuroQoL - European Quality of Life ), 5-25 points, the lower score means better outcome

Sponsors and collaborators

Lead sponsor

University of Tartu

Other

Registry information

Official study title

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

Acronym: AMESI

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 1, 2022
Registry last updated
May 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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