Non-Occlusive Mesenteric IschemiaNCT06970015
Demographics, Diagnosis, Management, and Outcomes of Non-occlusive Mesenteric Ischemia.
An observational study of Non-Occlusive Mesenteric Ischemia, run by University of Tartu at 1 site in Estonia.
Trial summary
This prospective multicenter observational study, conducted between June , 2022, and April, 2023, is a preplanned analysis of the AMESI study titled 'Demographics, diagnosis, management, and outcomes of non-occlusive mesenteric ischemia,' aiming primarily to describe the demographic profile, clinical presentation, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Occlusive Mesenteric Ischemia
- How many people
- 566 participants
- Where
- 1 siteEstonia
- Study dates
- 6 Jun 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Study groups * Patients with non-occlusive mesenteric ischemia. * Patients with arterial occlusive AMI * Patients with venous occlusive AMI * Patients with unclear mechanism of AMI * Patients with suspected but not confirmed AMI * Patients with suspected but not confirmed acute mesenteric ischemia * Patients with suspected but not confirmed acute mesenteric ischemia treated in the ICU
Who may be able to join
- All at least 18-year-old patients with acute mesenteric ischemia or patients suspected of acute mesenteric ischemia that was not confirmed
- Patients with arterial occlusive AMI
- Patients with non-occlusive mesenteric ischemia
- Patients with venous occlusive AMI
- Patients with unclear mechanism of AMI
- Patients with suspected but not confirmed AMI
Who cannot join
- Patients with other specific form of AMI (e.g dissection)
- Confirmed strangulating bowel obstruction
- Individuals under 18 years of age.
- Consent declined by patient or next of kin
- Chronic mesenteric ischaemia without an acute event
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Demographics, Diagnosis, Management, and Outcomes of Non-occlusive Mesenteric Ischemia: a Substudy of a Prospective Multicenter Observational Study (AMESI)
This prospective multicenter observational study, conducted between June , 2022, and April, 2023, is a preplanned analysis of the AMESI study titled 'Demographics, diagnosis, management, and outcomes of non-occlusive mesenteric ischemia,' aiming primarily to describe the demographic profile, clinical presentation, and laboratory findings of patients with non-occlusive mesenteric ischemia (NOMI), and secondarily to identify independent risk factors as well as diagnostic approaches, management strategies, and outcomes-including in-hospital, 90-day, and one-year results.
- Conditions
- Non-Occlusive 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, this is an observational study on patients with suspected acute mesenteric ischemia
| Study group | Role | What they receive |
|---|---|---|
| Patients with non-occlusive mesenteric ischemia | Patients with non-occlusive mesenteric ischemia, n=55 Receives: Other: No intervention | |
| Patients with arterial occlusive mesenteric ischemia | Patients with arterial occlusive mesenteric ischemia, n=231 Receives: Other: No intervention | |
| Patients with venous occlusive mesenteric ischemia | Patients with arterial occlusive mesenteric ischemia, n=73 Receives: Other: No intervention | |
| Patients with unclear mechanism of acute mesenteric ischemia | Patients with unclear mechanism of acute mesenteric ischemia, n=48 Receives: Other: No intervention | |
| Patients with suspected but not confirmed acute mesenteric ischemia | Patients with suspected but not confirmed acute mesenteric ischemia, n=159 Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic profile
One of the primary objectives is to describe the baseline demographic profile of patients with non-occlusive mesenteric ischemia. The demographic data will include the following information:
- Gender (Male or Female)
- Age (in years)
- BMI (calculated from body weight in kilograms and height in centimeters)
Measured: Baseline
SOFA score
Sequential Organ Failure Assessment (SOFA) score. Range: 0-24. Higher scores indicate more severe organ dysfunction.
Measured: Baseline
Serum Lactate Levels in Patients with Non-Occlusive Mesenteric Ischemia
Serum lactate level measured in mmol/L. Higher values indicate worse tissue perfusion.
Measured: Baseline
Baseline APACHE II Score
Acute Physiology and Chronic Health Evaluation II (APACHE II) score. Range: 0-71. Higher scores indicate more severe disease and higher predicted mortality.
Measured: Baseline
Arterial Blood pH in Patients with Non-Occlusive Mesenteric Ischemia
Arterial pH level. Normal range is 7.35-7.45. Lower values indicate acidosis.
Measured: Baseline
Secondary outcomes (4)
Rate of Patients Diagnosed with Non-Occlusive Mesenteric Ischemia by CT, Endoscopy, or Angiography
Percentage of participants diagnosed with non-occlusive mesenteric ischemia (NOMI) using computed tomography (CT), endoscopy, or angiography.
Measured: Baseline
Management
Rate of surgical, conservative, endovascular or palliative management
Measured: Baseline
30-day survival
30-day Survival of patients with non-occlusive mesenteric ischemia
Measured: 30 days after admission
1-year survival
1-year survival of patients with non-occlusive mesenteric ischemia
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 posted14 May 2025
- Study start6 Jun 2022
- Primary completion5 Apr 2023
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Occlusive 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
- 566 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vladislav Mihnovitš, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970015
- Sponsor's protocol ID
- NOMI-AMESI
- Status last verified
- May 2025
- First submitted
- 18 Apr 2025
- Last updated
- 14 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demographics, Diagnosis, Management, and Outcomes of Non-occlusive Mesenteric Ischemia: a Substudy of a Prospective Multicenter Observational Study (AMESI)
- ClinicalTrials.gov ID
- NCT06970015
- Acronym / sponsor ID
- NOMI-AMESI
- Conditions
- Non-Occlusive Mesenteric Ischemia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 566 participants (actual)
- Lead sponsor
- University of TartuUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 5 Apr 2023 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 May 2025 (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 prospective multicenter observational study, conducted between June , 2022, and April, 2023, is a preplanned analysis of the AMESI study titled 'Demographics, diagnosis, management, and outcomes of non-occlusive mesenteric ischemia,' aiming primarily to describe the demographic profile, clinical presentation, and laboratory findings of patients with non-occlusive mesenteric ischemia (NOMI), and secondarily to identify independent risk factors as well as diagnostic approaches, management strategies, and outcomes-including in-hospital, 90-day, and one-year results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Patients with non-occlusive mesenteric ischemia | – | Other: No interventionPatients with non-occlusive mesenteric ischemia, n=55 |
| Patients with arterial occlusive mesenteric ischemia | – | Other: No interventionPatients with arterial occlusive mesenteric ischemia, n=231 |
| Patients with venous occlusive mesenteric ischemia | – | Other: No interventionPatients with arterial occlusive mesenteric ischemia, n=73 |
| Patients with unclear mechanism of acute mesenteric ischemia | – | Other: No interventionPatients with unclear mechanism of acute mesenteric ischemia, n=48 |
| Patients with suspected but not confirmed acute mesenteric ischemia | – | Other: No interventionPatients with suspected but not confirmed acute mesenteric ischemia, n=159 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Study groups * Patients with non-occlusive mesenteric ischemia. * Patients with arterial occlusive AMI * Patients with venous occlusive AMI * Patients with unclear mechanism of AMI * Patients with suspected but not confirmed AMI * Patients with suspected but not confirmed acute mesenteric ischemia * Patients with suspected but not confirmed acute mesenteric ischemia treated in the ICU
Key inclusion criteria (6 listed)
- All at least 18-year-old patients with acute mesenteric ischemia or patients suspected of acute mesenteric ischemia that was not confirmed
- Patients with arterial occlusive AMI
- Patients with non-occlusive mesenteric ischemia
- Patients with venous occlusive AMI
- Patients with unclear mechanism of AMI
Key exclusion criteria (5 listed)
- Patients with other specific form of AMI (e.g dissection)
- Confirmed strangulating bowel obstruction
- Individuals under 18 years of age.
- 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, this is an observational study on patients with suspected acute mesenteric ischemia | Other | Patients with arterial occlusive mesenteric ischemia, Patients with non-occlusive mesenteric ischemia, Patients with suspected but not confirmed acute mesenteric ischemia, Patients with unclear mechanism of acute mesenteric ischemia, Patients with venous occlusive mesenteric ischemia |
Primary outcome
Demographic profile
Time frame: Baseline
One of the primary objectives is to describe the baseline demographic profile of patients with non-occlusive mesenteric ischemia. The demographic data will include the following information: 1. Gender (Male or Female) 2. Age (in years) 3. BMI (calculated from body weight in kilograms and height in centimeters)
SOFA score
Time frame: Baseline
Sequential Organ Failure Assessment (SOFA) score. Range: 0-24. Higher scores indicate more severe organ dysfunction.
Serum Lactate Levels in Patients with Non-Occlusive Mesenteric Ischemia
Time frame: Baseline
Serum lactate level measured in mmol/L. Higher values indicate worse tissue perfusion.
Baseline APACHE II Score
Time frame: Baseline
Acute Physiology and Chronic Health Evaluation II (APACHE II) score. Range: 0-71. Higher scores indicate more severe disease and higher predicted mortality.
Arterial Blood pH in Patients with Non-Occlusive Mesenteric Ischemia
Time frame: Baseline
Arterial pH level. Normal range is 7.35-7.45. Lower values indicate acidosis.
4 secondary outcomes
Rate of Patients Diagnosed with Non-Occlusive Mesenteric Ischemia by CT, Endoscopy, or Angiography
Time frame: Baseline
Management
Time frame: Baseline
30-day survival
Time frame: 30 days after admission
1-year survival
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Non-Occlusive Mesenteric Ischemia
RecruitingObservational study
Predictors of Transmural Non-Occlusive Mesenteric Ischemia in ICU Patients With Suspected Acute Mesenteric Ischemia
Non-Occlusive Mesenteric Ischaemia (NOMI), Acute Mesenteric Ischemia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Occlusive Mesenteric Ischemia, run by University of Tartu at 1 site in Estonia.
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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. 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?
This study is still under way. Results are not available in the source record yet.
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?
Demographic profile (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2025.