Promoting Early Diagnosis of Chronic Mesenteric Ischemia

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Mesenteric Ischemia

Intervention / Treatment
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* Diagnostic Test: 13C-butyrate breath test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a clinical suspicion of CMI referred to to Maagdarm Ischemie Centrum Rotterdam (MICR). 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: 13C-butyrate breath test|breath test|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breath test, chronic mesenteric ischemie, calcium scoring