Promoting Early Diagnosis of Chronic Mesenteric Ischemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 13C-butyrate breath test.
- Who it may be relevant to
- Registry conditions: Chronic Mesenteric Ischemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Diagnostic test 13C-butyrate breath test
breath test
Primary outcome measures
- Breath test [Time frame: 2023-2025]
- calcium scores [Time frame: 2023-2035]
Eligibility criteria
Inclusion criteria
- Patients with a clinical suspicion of CMI referred to Maagdarm Ischemie Centrum Rotterdam (MICR), MST or UMCG.
- Patients ≥ 18 years
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 4 centers
- Medisch Spectrum Twente — Enschede
- University Medical Centre Groningen — Groningen
- Erasmus University Medical Centre Rotterdam — Rotterdam
- Franciscus — Rotterdam
Identifiers
NCT: NCT05735002 · 9933