About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with a clinical suspicion of CMI referred to Maagdarm Ischemie Centrum Rotterdam (MICR), MST or UMCG.
Patients ≥ 18 years
Disqualifiers
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
Trial population
All patients with suspected CMI
Trial design
Cohort
Prospective
Treatments tested in this trial
13C-butyrate breath test
Diagnostic testbreath test
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Erasmus Medical Center
Lead sponsor
Maag Lever Darm Stichting
Collaborator