Promoting Early Diagnosis of Chronic Mesenteric Ischemia
PROMISE
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
1 other identifier
observational
296
1 country
4
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2024
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2023
CompletedFirst Posted
Study publicly available on registry
February 21, 2023
CompletedStudy Start
First participant enrolled
February 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
July 4, 2025
July 1, 2025
2.9 years
February 9, 2023
July 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
2023-2035
Study Arms (1)
Patients with suspected CMI
Patients with suspected CMI
Interventions
Eligibility Criteria
All patients with suspected CMI
You may qualify if:
- Patients with a clinical suspicion of CMI referred to Maagdarm Ischemie Centrum Rotterdam (MICR), MST or UMCG.
- Patients ≥ 18 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Erasmus Medical Centerlead
- Maag Lever Darm Stichtingcollaborator
Study Sites (4)
Medisch Spectrum Twente
Enschede, Overijssel, 7512KZ, Netherlands
University Medical Centre Groningen
Groningen, Provincie Groningen, 9713GZ, Netherlands
Erasmus University Medical Centre Rotterdam
Rotterdam, South Holland, 3015GD, Netherlands
Franciscus
Rotterdam, South Holland, 3045PM, Netherlands
Biospecimen
Blood samples will be collected to search for specific biomarkers for chronic mesenteric ischemia
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Gastroenterologist
Study Record Dates
First Submitted
February 9, 2023
First Posted
February 21, 2023
Study Start
February 1, 2024
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
July 4, 2025
Record last verified: 2025-07