Chronic Mesenteric IschemiaPROMISENCT05735002
Promoting Early Diagnosis of Chronic Mesenteric Ischemia
An observational study of Chronic Mesenteric Ischemia, run by Erasmus Medical Center at 4 sites in Netherlands.
Trial summary
CMI is an incapacitating disease and timely diagnosis remains problematic. Despite the substantial compensatory capacity of the mesenteric circulation CMI is relatively common, its incidence being comparable to other well-known diseases like Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Mesenteric Ischemia
- What is being tested?
- 13C-butyrate breath test
- How many people
- 296 participants
- Where
- 4 sitesNetherlands
- Study dates
- 1 Feb 2024to 1 Apr 2027
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients with suspected CMI
Who may be able to join
- Patients with a clinical suspicion of CMI referred to Maagdarm Ischemie Centrum Rotterdam (MICR), MST or UMCG.
- Patients ≥ 18 years
Who cannot join
- Patients who are unable to give informed consent
- Patients with previous mesenteric artery revascularization
- No available CT imaging and contraindications for CT imaging (e.g. pregnancy)
- Common origin of the celiac artery and superior mesenteric artery
- Known delayed gastric emptying
- Known and untreated small intestinal bacterial overgrowth
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Desirée Leemreis - van Noord, MD, PhD contact
Netherlands4 sites, 4 recruiting
- Not yet recruiting
Medisch Spectrum Twente
Enschede, Overijssel, 7512KZ
- Not yet recruiting
University Medical Centre Groningen
Groningen, Provincie Groningen, 9713GZ
- Recruiting
Erasmus University Medical Centre Rotterdam
Rotterdam, South Holland, 3015GD
- Recruiting
Franciscus
Rotterdam, South Holland, 3045PM
About this study
Official title: PRomoting Early Diagnosis Of Chronic Mesenteric ISchEmia by a Mesenteric Artery Calcium Score Based Risk Stratification and Detection of Postprandial Mucosal Ischemia by Butyrate Breath Testing
CMI is an incapacitating disease and timely diagnosis remains problematic. Despite the substantial compensatory capacity of the mesenteric circulation CMI is relatively common, its incidence being comparable to other well-known diseases like Crohn's disease.
Diagnostic tools are needed for two purposes since the exclusion of CMI currently requires a cumbersome complication-prone diagnostic workup and since a definitive diagnosis is mainly established per exclusionem. First, a sensitive test is desirable to rule out CMI and avoid excessive diagnostic investigations. Quantification of mesenteric arterial calcification on computed tomography (CT) seems suitable for this purpose, synonymous with the coronary artery calcium score. Second, a specific test is required confirming CMI by detection of mucosal ischemia during a meal, when oxygen demand peaks. A breath test, based on the requirement of oxygen to absorb and metabolize 13C-butyrate in the enterocyte, could detect mucosal ischemia
Read more
Objective: Facilitating diagnosis of chronic mesenteric ischemia (CMI) using 1) the mesenteric artery calcium score (MACS) and 2) mucosal ischemia detection by butyrate breath testing
Study design: Multicentre prospective cohort studies.
- Conditions
- Chronic Mesenteric Ischemia
- Being tested
- 13C-butyrate breath test
- Keywords
- breath test, chronic mesenteric ischemie, calcium scoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13C-butyrate breath testDiagnostic test
breath test
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected CMI | Patients with suspected CMI Receives: Diagnostic Test: 13C-butyrate breath test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breath test
- To validate the butyrate breath test as a specific functional test with a high positive predictive value to rightfully diagnose and select patients who will benefit from invasive treatment.
Measured: 2023-2025
calcium scores
To validate the mesenteric artery calcium score as a readily available, easy, and sensitive test with a high negative predictive value to either rule out CMI or select patients for further investigations.
Measured: 2023-2035
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Feb 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Mesenteric IschemiaStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- 296 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Maag Lever Darm Stichting
- Responsible party
- Principal investigator, Marco J. Bruno, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735002
- Sponsor's protocol ID
- 9933
- Acronym
- PROMISE
- Status last verified
- Jul 2025
- First submitted
- 9 Feb 2023
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- 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 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRomoting Early Diagnosis Of Chronic Mesenteric ISchEmia by a Mesenteric Artery Calcium Score Based Risk Stratification and Detection of Postprandial Mucosal Ischemia by Butyrate Breath Testing
- ClinicalTrials.gov ID
- NCT05735002
- Acronym / sponsor ID
- PROMISE / 9933
- Conditions
- Chronic Mesenteric Ischemia
- Keywords
- breath test, chronic mesenteric ischemie, calcium scoring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 296 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Maag Lever Darm Stichting
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 21 Feb 2023 (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.
CMI is an incapacitating disease and timely diagnosis remains problematic. Despite the substantial compensatory capacity of the mesenteric circulation CMI is relatively common, its incidence being comparable to other well-known diseases like Crohn's disease.
Diagnostic tools are needed for two purposes since the exclusion of CMI currently requires a cumbersome complication-prone diagnostic workup and since a definitive diagnosis is mainly established per exclusionem. First, a sensitive test is desirable to rule out CMI and avoid excessive diagnostic investigations. Quantification of mesenteric arterial calcification on computed tomography (CT) seems suitable for this purpose, synonymous with the coronary artery calcium score. Second, a specific test is required confirming CMI by detection of mucosal ischemia during a meal, when oxygen demand peaks. A breath test, based on the requirement of oxygen to absorb and metabolize 13C-butyrate in the enterocyte, could detect mucosal ischemia
Objective: Facilitating diagnosis of chronic mesenteric ischemia (CMI) using 1) the mesenteric artery calcium score (MACS) and 2) mucosal ischemia detection by butyrate breath testing
Study design: Multicentre prospective cohort studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected CMI | – | Diagnostic Test: 13C-butyrate breath testPatients with suspected CMI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with suspected CMI
Key inclusion criteria (2 listed)
- Patients with a clinical suspicion of CMI referred to Maagdarm Ischemie Centrum Rotterdam (MICR), MST or UMCG.
- Patients ≥ 18 years
Key exclusion criteria (6 listed)
- Patients who are unable to give informed consent
- Patients with previous mesenteric artery revascularization
- No available CT imaging and contraindications for CT imaging (e.g. pregnancy)
- Common origin of the celiac artery and superior mesenteric artery
- Known delayed gastric emptying
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 |
|---|---|---|
| 13C-butyrate breath testbreath test | Diagnostic test | Patients with suspected CMI |
Primary outcome
Breath test
Time frame: 2023-2025
- To validate the butyrate breath test as a specific functional test with a high positive predictive value to rightfully diagnose and select patients who will benefit from invasive treatment.
calcium scores
Time frame: 2023-2035
To validate the mesenteric artery calcium score as a readily available, easy, and sensitive test with a high negative predictive value to either rule out CMI or select patients for further investigations.
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 4 Jul 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Mesenteric Ischemia
Active, not recruitingObservational study
Investigation of Chronic Intestinal Ischemia
Chronic Mesenteric Ischemia
Not yet recruitingObservational study
Blood Flow and Oxygenation in the Portal Vein in Subjects With Chronic Narrowing of the Blood Vessels to the Gut
Chronic Mesenteric Ischemia
RecruitingObservational study
Translesional PRESSURE Measurements to Assess Clinical Relevance of a Mesenteric Artery Stenosis (PRESSURE-study)
Chronic Mesenteric Ischemia, Ischemia, Mesenteric
RecruitingObservational study
Intestinal Ischemia Biomarker in Patients With Chronic Mesenteric Ischemia
Chronic Mesenteric Ischemia, Median Arcuate Ligament Syndrome
Not yet recruitingObservational study
European Multicentre Study of Long-term Results Following Visceral Arteries Revascularization: the E-VisAR Study
Visceral Artery Aneurysm, Mesenteric Artery 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.
Desirée Leemreis - van Noord, MD, PhD contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Mesenteric Ischemia, run by Erasmus Medical Center at 4 sites in Netherlands.
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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. 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?
Contact Eva Karina Bocharewicz, MD, PhD Candidate (0031652216196, e.bocharewicz@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breath test (time frame: 2023-2025). The study lists 2 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 4 Jul 2025.