Acute Mesenteric IschemiaAMESINCT05218863
Incidence, Diagnosis, Management and Outcome of Acute Mesenteric Ischemia
An observational study of Acute Mesenteric Ischemia, run by University of Tartu at 3 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Mesenteric Ischemia
- How many people
- 709 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 6 Jun 2022to 5 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- All patients with suspected AMI
Who cannot join
- Age <18 years Consent declined by patient or next of kin Chronic mesenteric ischaemia without an acute event
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Estonia2 sites
North Estonian Regional Hospital
Tallinn
Tartu University Hospital
Tartu
About this study
Official title: Incidence, Diagnosis, Management and Outcome of Acute Mesenteric Ischaemia: a Prospective, Multicentre Observational Study
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.
Read more
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
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AMI
Incidence of AMI in hospitalized adult patients in acute care hospitals
Measured: 6 months
Secondary outcomes (7)
30 days survival of AMI
survival of patients with confirmed AMI
Measured: 30 days after admission/suspicion of AMI/study inclusion
Proportion of different forms of AMI
Proportion of each form of AMI from all AMI cases
Measured: 6 months
Time to diagnosis
Time from symptoms to diagnosis
Measured: through study completion, study duration 6 months
Time to treatment
Time from diagnosis to treatment
Measured: through study completion, study duration 6 months
Treatment
Surgery, endovascular intervention or palliation
Measured: through study completion, study duration 6 months
1 year survival
Survival of patients with AMI 1 year after diagnosis
Measured: 1 year
Quality of life score
EQ-5D-5L (EuroQoL - European Quality of Life ), 5-25 points, the lower score means better outcome
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start6 Jun 2022
- Primary completion5 Apr 2023
- Study completion5 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Mesenteric IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 709 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annika Reintam Blaser, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218863
- Sponsor's protocol ID
- AMESI Study
- Acronym
- AMESI
- Status last verified
- May 2023
- First submitted
- 4 Jan 2022
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39600492Reintam 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.
PubMed 38263058
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Diagnosis, Management and Outcome of Acute Mesenteric Ischaemia: a Prospective, Multicentre Observational Study
- ClinicalTrials.gov ID
- NCT05218863
- Acronym / sponsor ID
- AMESI / AMESI Study
- Conditions
- Acute Mesenteric Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 709 participants (actual)
- Lead sponsor
- University of TartuUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 5 Apr 2023 (actual)
- Study completion
- 5 Apr 2023 (actual)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Confirmed AMI | – | Other: No interventionPatients 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. |
| AMI suspected but not confirmed | – | Other: No interventionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- All patients with suspected AMI
Key exclusion criteria (1 listed)
- Age <18 years Consent declined by patient or next of kin Chronic mesenteric ischaemia without an acute event
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | AMI suspected but not confirmed, Confirmed AMI |
Primary outcome
Incidence of AMI
Time frame: 6 months
Incidence of AMI in hospitalized adult patients in acute care hospitals
7 secondary outcomes
30 days survival of AMI
Time frame: 30 days after admission/suspicion of AMI/study inclusion
Proportion of different forms of AMI
Time frame: 6 months
Time to diagnosis
Time frame: through study completion, study duration 6 months
Time to treatment
Time frame: through study completion, study duration 6 months
Treatment
Time frame: through study completion, study duration 6 months
1 year survival
Time frame: 1 year
Quality of life score
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Derived from this study: PubMed 39600492Acosta 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.
- Derived from this study: PubMed 38263058Reintam 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Mesenteric Ischemia, run by University of Tartu at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Estonia, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AMI (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05218863, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.